Product Code: HRX FDA class 2 21 CFR 888.1100

Arthroscope

Orthopedic

An arthroscope is a rigid or flexible endoscopic device inserted into a joint cavity to allow direct visual examination and surgical intervention within joints such as the knee, shoulder, or hip. It is classified as an FDA Class 2 device under 21 CFR 888.1100, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRX falls under the Orthopedic medical specialty. Per FDA guidance, if the arthroscope is reusable and has specific design features requiring validated reprocessing, reprocessing validation data must be included in any 510(k) submission (refer to 82 FR 26807, June 9, 2017). This device is eligible for third party review.

View on FDA

510(k)s

670

FEI Numbers

368

Registration Numbers

368

Unique Applicants

289

Years Active

Basic Information

Product Code: HRX
Device Class: FDA class 2
Regulation Number: 888.1100
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 670 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243602	Arthrex Spine Endoscope	May 16, 2025	Substantially Equivalent	Arthrex, Inc.
K242417	VECTR Video Endoscopic Carpal Tunnel Release System	Dec 11, 2024	Substantially Equivalent	Rafael Medical Devices, LLC
K243020	MIDASVu	Dec 02, 2024	Substantially Equivalent	IntraVu, Inc.
K233800	Vertos mild Device Kit (MDK-0002)	May 06, 2024	Substantially Equivalent	Vertos Medical Inc
K240535	Digital ClarusScope System; Digital NeuroPEN System	Apr 25, 2024	Substantially Equivalent	Clarus Medical, LLC
K233675	FMS VUE Fluid Management and Tissue Debridement System	Feb 26, 2024	Substantially Equivalent	DePuy Mitek, Inc.
K233115	Hawkeye Control Unit with Eyas Endoscope	Feb 06, 2024	Substantially Equivalent	E Surgical, LLC
K223709	Kyphoplasty Balloon Catheter	Aug 16, 2023	Substantially Equivalent	Jiangsu Changmei Medtech Co., Ltd.
K221142	Kyphoplasty Balloon System	Apr 21, 2023	Substantially Equivalent	OK MediNet Korea Co., Ltd.
K221919	DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets	Mar 09, 2023	Substantially Equivalent	Hemodia SAS
K223406	SmartRelease Endoscopic Soft Tissue Release System	Feb 02, 2023	Substantially Equivalent	MicroAire Surgical Instruments
K223244	Pristine Arthroscopic Visualization System	Dec 21, 2022	Substantially Equivalent	Pristine Surgical
K222490	HBL Blade Assembly	Nov 14, 2022	Substantially Equivalent	Hand Biomechanics Lab, Inc
K213978	TELIGEN System	Oct 18, 2022	Substantially Equivalent	Medos International, SARL
K212636	CORUS Spinal System-X	Oct 15, 2021	Substantially Equivalent	Providence Medical Technology, Inc.
K212556	mi-eye 3 needlescope with cannula, mi-tablet 3	Sep 15, 2021	Substantially Equivalent	Trice Medical, Inc.
K211297	SMARTRELEASE Endoscopic Soft Tissue Release System	Jun 24, 2021	Substantially Equivalent	MicroAire Surgical Instruments
K203480	DOUBLEFLO system	Apr 05, 2021	Substantially Equivalent	Hemodia SAS
K202027	Balex bone Expander System	Feb 03, 2021	Substantially Equivalent	Taeyeon Medical Co., Ltd.
K193608	EBERLE Shaver System C3 and Accessories	Jan 15, 2021	Substantially Equivalent	Eberle GmbH & Co. KG
K203526	C Scope Visualization System	Jan 12, 2021	Substantially Equivalent	CIT Ortho
K201113	Resascope RS-01/B	Dec 21, 2020	Substantially Equivalent	Advanced Medical Systems Group SRL
K202659	Stryker Arthroscope	Dec 01, 2020	Substantially Equivalent	Stryker
K192921	Zeos Aqua Vision Pump and tube	Oct 09, 2020	Substantially Equivalent	Hemodia SAS
K200067	MectaScope System	Oct 01, 2020	Substantially Equivalent	Medacta International SA
K200763	Osteo-site Vertebral Balloon	Aug 12, 2020	Substantially Equivalent	IZI Medical
K201349	Smith+Nephew Arthroscopes	Jul 20, 2020	Substantially Equivalent	Smith & Nephew
K200729	HydroCision SpineJet System	Apr 16, 2020	Substantially Equivalent	HydroCision, Inc.
K191596	Arcadia Balloon Catheter	Oct 09, 2019	Substantially Equivalent	Merit Medical Systems, Inc.
K192155	Smith & Nephew DYONICS 25 Fluid Management System	Sep 04, 2019	Substantially Equivalent	Smith & Nephew, Inc.
K191345	Pegasus System	Jul 17, 2019	Substantially Equivalent	A.M. Surgical, Inc.
K191259	Stryker CrossFlow Integrated Arthroscopy Pump	Jul 12, 2019	Substantially Equivalent	Stryker Corp.
K191594	Nuvis Battery Arthroscope	Jul 11, 2019	Substantially Equivalent	Integrated Endoscopy, Inc.
K191579	Voyant System	Jul 11, 2019	Substantially Equivalent	Viseon, Inc.
K190804	HydroCision TenJet Device	Jun 05, 2019	Substantially Equivalent	HydroCision, Inc.
K182287	MEDINAUT Plus	Apr 06, 2019	Substantially Equivalent	Imedicom Co., Ltd.
K190598	CROSSWAY Spinal Access System	Apr 05, 2019	Substantially Equivalent	Globus Medical Inc.
K190201	CORUS Spinal System	Mar 08, 2019	Substantially Equivalent	Providence Medical Technology, Inc.
K183165	Pristine Scope	Jan 16, 2019	Substantially Equivalent	Pristine Surgical
K183470	Precision Ideal Eyes Arthroscopes	Jan 07, 2019	Substantially Equivalent	Stryker
K181752	Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)	Dec 21, 2018	Substantially Equivalent	Stryker Corporation
K182882	CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control	Nov 14, 2018	Substantially Equivalent	Conmed Corporation
K181819	SMARTRELEASE Endoscopic Soft Tissue Release System	Nov 06, 2018	Substantially Equivalent	MicroAire Surgical Instruments LLC
K181885	Voyant System	Oct 02, 2018	Substantially Equivalent	Viseon, Inc.
K181982	MIDAScope and Introducer Kit, and MIDASystem	Aug 21, 2018	Substantially Equivalent	IntraVu, Inc.
K180766	Endiscope, Endiscope Cervical	Jun 11, 2018	Substantially Equivalent	Elliquence, LLC
K170703	Single Use Arthroscopic Electrode (with Pencil)	May 31, 2018	Substantially Equivalent	Modern Medical Equipment Manufacturing Limited
K180876	DTRAX Spinal System	May 18, 2018	Substantially Equivalent	Providence Medical Technology, Inc.
K173311	ARTHRO-Pump PA304	May 09, 2018	Substantially Equivalent	W.O.M. World of Medicine GmbH
K180315	DISKOM	Mar 26, 2018	Substantially Equivalent	Biopsybell s.r.l.
K172116	Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)	Jan 25, 2018	Substantially Equivalent	Stryker Corporation
K171237	FMS VUE II Fluid Management and Tissue Debridement System	Jan 18, 2018	Substantially Equivalent	Medos International SARL
K172092	Reprocessed Shavers/Burs	Oct 04, 2017	Substantially Equivalent	Renovo, Inc.
K171794	Smith & Nephew 25 Fluid Management System	Jun 27, 2017	Substantially Equivalent	Smith & Nephew, Inc.
K162070	JOINIX CANNULAR SYSTEM	Mar 16, 2017	Substantially Equivalent	AJU Pharm Co.,Ltd.
K163037	Intra medullary endo-transilluminating device (iMET device)	Feb 17, 2017	Substantially Equivalent	WEMED BIO-TECH INC.
K162062	AVAmax Vertebral Balloon, AVAflex Vertebral Balloon	Nov 01, 2016	Substantially Equivalent	STRYKER CORPORATION
K161878	PORTAGE System	Sep 26, 2016	Substantially Equivalent	Baylis Medical Company Inc.
K162475	mi-eye 2, mi-eye 2 monitor	Sep 16, 2016	Substantially Equivalent	Trice Medical
K152511	Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula	Jul 11, 2016	Substantially Equivalent	PROSURG, INC
K160249	ULTRA Telescopes	Apr 21, 2016	Substantially Equivalent	Olympus Winter & Ibe GmbH
K151932	Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing	Mar 31, 2016	Substantially Equivalent	STRYKER CORPORATION
K151268	SPINAUT-V, SPINAUT-S, SPINAUT-I	Mar 16, 2016	Substantially Equivalent	IMEDICOM CO., LTD.
K153548	VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM	Feb 22, 2016	Substantially Equivalent	VISIONSENSE LTD
K151125	AVAflex Vertebral Balloon System	Nov 24, 2015	Substantially Equivalent	CAREFUSION
K150523	AVAmax Vertebral Balloon	Oct 29, 2015	Substantially Equivalent	CAREFUSION
K151532	KYPHON ELEMENT Inflatable Bone Tamp	Jul 23, 2015	Substantially Equivalent	MEDTRONIC, INC.
K143705	NeedleCam HD Visualization System	Feb 20, 2015	Substantially Equivalent	BIOVISION TECHNOLOGIES, LLC
K141557	HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR	Dec 08, 2014	Substantially Equivalent	GALLINI MEDICAL DEVICES, SRL
K141326	NEEDLE VIEW CH SCOPE KITS	Oct 08, 2014	Substantially Equivalent	BIOVISION TECHNOLOGIES, LLC
K141119	CAMERA ENABLED PROBE	Jul 29, 2014	Substantially Equivalent	TRICE MEDICAL, INC.
K140903	NUVIS ARTHROSCOPE	Jul 17, 2014	Substantially Equivalent	INTEGRATED ENDOSCOPY, INC.
K141002	VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM	Jun 26, 2014	Substantially Equivalent	Visionsense Ltd.
K133682	SCHOELLY ARTHROSCOPE	Jun 02, 2014	Substantially Equivalent	SCHOLLY FIBEROPTIC GMBH
K133941	MITEK ARTHROSCOPES	Apr 18, 2014	Substantially Equivalent	MEDOS INTERNATIONAL SARL
K130778	DISCOSCOPES, CERVICAL ENDOSCOPES	Apr 14, 2014	Substantially Equivalent	RZ MEDIZINTECHNIK GMBH
K133018	OSI Q SYSTEM ARTHROSCOPES	Feb 26, 2014	Substantially Equivalent	ORTHOPEDIC SCIENCES, INC
K133061	ESPIN SYSTEM	Nov 27, 2013	Substantially Equivalent	NLT SPINE LTD
K132883	HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)	Nov 01, 2013	Substantially Equivalent	HEMODIA S.A.S.
K131820	AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G	Oct 04, 2013	Substantially Equivalent	CAREFUSION
K131824	AVAFLEX VERTEBRAL BALLOON SYSTEM	Oct 03, 2013	Substantially Equivalent	CAREFUSION
K131191	4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS	Jul 22, 2013	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K130912	OMNICUT RESECTION BLADE	Jun 14, 2013	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K130430	IVAS 10MM AND 15MM BALLOON CATHETER	May 23, 2013	Substantially Equivalent	STRYKER CORPORATION
K130169	FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE	May 01, 2013	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K122411	J-SCOPE SYSTEM	Feb 11, 2013	Substantially Equivalent	MYELOTEC
K130057	ESPIN	Feb 07, 2013	Substantially Equivalent	NLT SPINE LTD
K123441	STRYKER CROSSFLOW ARTHROSCOPY PUMP	Jan 09, 2013	Substantially Equivalent	Stryker Endoscopy
K121261	ASAP MUITISCOPE	Jan 08, 2013	Substantially Equivalent	ASAP ENDOSCOPIC PRODUCTS GMBH
K122134	FLEXLITE CAMERA	Dec 27, 2012	Substantially Equivalent	SPINE VIEW, INC.
K123771	KYPHON EXPRESS II INFLATABLE BONE TAMPS	Dec 21, 2012	Substantially Equivalent	Medtronic
K122861	XTOOL	Dec 07, 2012	Substantially Equivalent	OUROBOROS MEDICAL
K122662	VERTIFLEX DIRECT DECOMPRESSION SYSTEM	Nov 13, 2012	Substantially Equivalent	VERTIFLEX, INC.
K121482	INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY	Aug 28, 2012	Substantially Equivalent	THEKEN SPINE LLC
K121548	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)	Aug 16, 2012	Substantially Equivalent	SPINE VIEW, INC.
K112548	ALTOMEC ARTHROSCOPE	Aug 15, 2012	Substantially Equivalent	ALTOMEC ENDOSCOPY INC
K120553	ESPIN	Aug 09, 2012	Substantially Equivalent	NLT SPINE LTD
K120680	ENSPIRE DISCECTOMY SYSTEM	Jun 26, 2012	Substantially Equivalent	SPINE VIEW, INC.
K113352	TRANSCORP SPINAL ACCESS SYSTEM	Apr 16, 2012	Substantially Equivalent	TRANSCORP, INC.
K113362	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)	Feb 10, 2012	Substantially Equivalent	SPINE VIEW, INC.
K113028	MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS	Dec 20, 2011	Substantially Equivalent	MEDISISS
K110992	ENSPIRE DEBRIDER SYSTEM	Oct 21, 2011	Substantially Equivalent	SPINE VIEW, INC.
K103231	KYPHON INFLATION SYRINGE	Jan 24, 2011	Substantially Equivalent	MEDTRONIC SPINE LLC
K093471	KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP	Oct 18, 2010	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K101864	KYPHON XPANDER II INFLATABLE BONE TAMP	Oct 14, 2010	Substantially Equivalent	Medtronic
K092723	AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM	Oct 04, 2010	Substantially Equivalent	SKELETAL DYNAMICS, LLC
K092977	EBERLE SHAVER SYSTEM ACCESSORIES	Sep 29, 2010	Substantially Equivalent	EFS EBERLE FEINWERKTECHNISCHE SYSTEME
K101734	VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES	Sep 08, 2010	Substantially Equivalent	VISIONSCOPE TECHNOLOGIES, LLC
K093677	STRYKER ARTHROSCOPE	Mar 05, 2010	Substantially Equivalent	Stryker Endoscopy
K093717	C-MOR VISUALIZATION DEVICE	Mar 02, 2010	Substantially Equivalent	AXIS SURGICAL TECHNOLOGIES, INC
K093409	POWERPUMP ARTHROSCOPY SYSTEM	Feb 24, 2010	Substantially Equivalent	MEDICAL VISION AB
K093062	VERTOS MEDICAL MILD DEVICE KIT	Feb 04, 2010	Substantially Equivalent	X-STEN CORP.
K092877	INDISCAL ASPIRATION DEVICE AND ACCESSORIES	Nov 17, 2009	Substantially Equivalent	BAYLIS MEDICAL CO., INC.
K083552	MAXMORESPINE TOM STICK	Oct 09, 2009	Substantially Equivalent	HOOGLAND SPINE PRODUCTS GMBH
K082841	SPINAL FORAMINOSCOPE	Sep 09, 2009	Substantially Equivalent	BLAZEJEWSKI MEDI-TECH GMBH
K091398	ARTHROSCOPE	Aug 26, 2009	Substantially Equivalent	ORTHOPEDIC SCIENCES, INC
K083707	ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE	Aug 03, 2009	Substantially Equivalent	ARTHREX, INC.
K090132	MAXMORESPINE SPINAL SYSTEM	Jun 09, 2009	Substantially Equivalent	HOOGLAND SPINE PRODUCTS GMBH
K090815	PERCUTANEOUS DISCECTOMY SYSTEM	May 21, 2009	Substantially Equivalent	LAURIMED LLC
K090303	XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004	Apr 30, 2009	Substantially Equivalent	CORESPINE TECHNOLOGIES, LLC
K090278	ENSPIRE DEBRIDER SYSTEM	Apr 15, 2009	Substantially Equivalent	SPINE VIEW, INC.
K083161	ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)	Mar 27, 2009	Substantially Equivalent	CONMED LINVATEC
K081240	TIGER DISCECTOMY DEVICE	Feb 27, 2009	Substantially Equivalent	SPINAL DEVICES, LLC
K082355	VISIONSENSE STEREOSCOPIC VISION SYSTEM	Dec 15, 2008	Substantially Equivalent	VISIONSENSE, LTD.
K082293	SURGVIEW INTEGRATED VISUALIZATION SYSTEM	Sep 09, 2008	Substantially Equivalent	BIOVISION TECHNOLOGIES, LLC
K082194	LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002	Aug 28, 2008	Substantially Equivalent	LAURIMED LLC
K081051	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	Aug 07, 2008	Substantially Equivalent	SPINE VIEW, INC.
K080122	SOPRO 670 ARTHROSCOPIC PUMP	Jul 11, 2008	Substantially Equivalent	SOPRO
K080617	POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES	Jun 27, 2008	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K072198	X-VOID, SPIDER	Jun 06, 2008	Substantially Equivalent	SINTEA BIOTECH, INC.
K080560	HENKE SASS WOLF OF AMERICA ARTHROSCOPE	Mar 18, 2008	Substantially Equivalent	HENKE SASS WOLF OF AMERICA, INC.
K072879	INNERVUE DIAGNOSTIC SCOPE SYSTEM	Jan 14, 2008	Substantially Equivalent	BIOMET ORTHOPEDICS, INC.
K070021	ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0	Dec 07, 2007	Substantially Equivalent	JG MEDICAL PRODUCTS LLC
K070874	ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR	Nov 02, 2007	Substantially Equivalent	ARTHRO KINETICS INC.
K072706	MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL	Oct 24, 2007	Substantially Equivalent	CONMED LINVATEC
K072675	SMITH & NEPHEW ARTHROSCOPE	Oct 15, 2007	Substantially Equivalent	SMITH & NEPHEW, INC.
K070233	CONMED LINVATEC SMART GUARD IRRIGATOR	Apr 02, 2007	Substantially Equivalent	CONMED LINVATEC
K063326	CONMED LINVATEC 24K IRRIGATION SYSTEM	Jan 31, 2007	Substantially Equivalent	CONMED LINVATEC
K062849	SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM	Jan 19, 2007	Substantially Equivalent	SMITH & NEPHEW, INC.
K062038	X-STEN MILD TOOL KIT, MODEL MTK-0001	Dec 19, 2006	Substantially Equivalent	X-STEN CORP.
K062380	FLOSIMPLE ARTHROSCOPY PUMP A120	Dec 14, 2006	Substantially Equivalent	W.O.M. WORLD OF MEDICINE AG
K061134	EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES	Sep 01, 2006	Substantially Equivalent	EFS EBERLE FEINWERKTECHNISCHE SYSTEME
K061246	ENDOSCOPIC SPINE SYSTEM	Aug 23, 2006	Substantially Equivalent	ARTHRO KINETICS INC.
K061345	MODIFICATION TO ENDIUS ATAVI SYSTEM	Jun 06, 2006	Substantially Equivalent	ENDIUS, INC.
K060172	REMA SHAVER BLADES	May 31, 2006	Substantially Equivalent	REMA MEDIZINTECHNIK GMBH.
K060198	MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW	May 11, 2006	Substantially Equivalent	LINVATEC CORP.
K053567	ATHROCARE TOPAZ ARTHROWANDS	Mar 06, 2006	Substantially Equivalent	ARTHROCARE CORP.
K052241	DISC-FX SYSTEM	Feb 24, 2006	Substantially Equivalent	ELLMAN INTERNATIONAL, INC.
K053267	ENDIUS ATAVI SYSTEM	Jan 13, 2006	Substantially Equivalent	ENDIUS, INC.
K051656	OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM	Oct 25, 2005	Substantially Equivalent	OSTEOBIOLOGICS, INC.
K051827	JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS LAMINOSCOPE/MULTISCOPE	Aug 12, 2005	Substantially Equivalent	JOIMAX GMBH
K051326	SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM	Jun 15, 2005	Substantially Equivalent	SMITH & NEPHEW, INC.
K050580	SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS	Apr 20, 2005	Substantially Equivalent	SMITH & NEPHEW ENDOSCOPY, INC.
K043568	EQUESTRA FLUID DELIVERY SYSTEM	Jan 25, 2005	Substantially Equivalent	MEDTRONIC SOFAMOR DANEK
K043395	SMITH & NEPHEW VIDEOARTHROSCOPE	Jan 12, 2005	Substantially Equivalent	SMITH & NEPHEW, INC.
K041824	X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM	Jan 07, 2005	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, SA
K041233	ARTHROJET XT	Jul 28, 2004	Substantially Equivalent	HYDROCISION, INC.
K040483	EQUESTRA FLUID DELIVERY SYSTEM	Jul 23, 2004	Substantially Equivalent	MEDTRONIC SOFAMOR DANEK, INC.
K041454	KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A	Jul 09, 2004	Substantially Equivalent	KYPHON, INC.
K040612	SKY BONE EXPANDER SYSTEM (SKY SYSTEM)	Jun 17, 2004	Substantially Equivalent	DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K040919	NUCLEOTOME PROBE SET, MODEL 21200	Jun 01, 2004	Substantially Equivalent	CLARUS MEDICAL, LLC.
K040939	SKY BONE EXPANDER SYSTEM (SKY SYSTEM)	May 12, 2004	Substantially Equivalent	DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K041135	VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES	May 10, 2004	Substantially Equivalent	DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
K033573	LINVATEC 10K IRRIGATION SYSTEM	Feb 11, 2004	Substantially Equivalent	LINVATEC CORP.
K034037	SKY BONE EXPANDER SYSTEM	Jan 28, 2004	Substantially Equivalent	DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K033927	ARTHOSCOPY PUMP A115	Jan 15, 2004	Substantially Equivalent	W.O.M. WORLD OF MEDICINE AG
K032891	TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT	Jan 15, 2004	Substantially Equivalent	TRANS1, INC.
K032358	B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)	Dec 17, 2003	Substantially Equivalent	DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
K032473	DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE	Nov 07, 2003	Substantially Equivalent	STRYKER INSTRUMENTS
K030082	POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851	Oct 30, 2003	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K032832	IRRIGATION SETS	Sep 26, 2003	Substantially Equivalent	VITAL CONCEPTS, INC.
K032529	HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310	Sep 16, 2003	Substantially Equivalent	HYDROCISION, INC.
K032212	KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A	Sep 15, 2003	Substantially Equivalent	KYPHON, INC.
K031972	ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,	Sep 15, 2003	Substantially Equivalent	ASAP ENDOSCOPIC PRODUCTS GMBH
K031605	INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY	Jun 18, 2003	Substantially Equivalent	SMITH & NEPHEW, INC.
K031406	EXOJET TISSUE MANAGEMENT SYSTEM	May 30, 2003	Substantially Equivalent	MITEK WORLDWIDE
K030402	ARTHROSCOPY PUMP, MODEL A107	Apr 17, 2003	Substantially Equivalent	W.O.M. WORLD OF MEDICINE AG
K030009	KSEA POWERSHAVER SYSTEM S2	Apr 02, 2003	Substantially Equivalent	KARL STORZ ENDOSCOPY
K024291	ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475	Mar 20, 2003	Substantially Equivalent	ARTHREX, INC.
K030096	VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW	Mar 18, 2003	Substantially Equivalent	ARTHREX, INC.
K030196	DYONICS POWER CONTROL UNIT	Feb 20, 2003	Substantially Equivalent	SMITH & NEPHEW, INC.
K030307	DAVOL ARTHROVENT OUTFLOW TUBING	Feb 13, 2003	Substantially Equivalent	DAVOL, INC.
K023783	SOHNIKS	Feb 07, 2003	Substantially Equivalent	SOHNIKS ENDOSCOPY, INC.
K023777	ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183	Dec 11, 2002	Substantially Equivalent	ARTHRONET MEDICAL, INC.
K023187	KSEA SPINOSCOPE	Dec 02, 2002	Substantially Equivalent	KARL STORZ ENDOSCOPY
K022199	ENDIUS ATAVI SYSTEM	Oct 02, 2002	Substantially Equivalent	ENDIUS, INC.
K020457	AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE	Sep 26, 2002	Substantially Equivalent	AXIAMED, INC.
K022578	ENDIUS FLEXTIP BLADE	Aug 23, 2002	Substantially Equivalent	ENDIUS, INC.
K021748	ENDIUS ATAVI SYSTEM	Jun 26, 2002	Substantially Equivalent	ENDIUS, INC.
K012667	REPROCESSED ARTHROSCOPIC SHAPERS	Jun 03, 2002	Substantially Equivalent	SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC.
K020761	POWER TEK II	Apr 03, 2002	Substantially Equivalent	BIOMET, INC.
K020688	HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR	Apr 03, 2002	Substantially Equivalent	HYDROCISION, INC.
K012640	ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS	Feb 28, 2002	Substantially Equivalent	MEDICAL INSTRUMENTS TECHNOLOGY, INC.
K020083	TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601	Feb 12, 2002	Substantially Equivalent	TUTA HEALTHCARE PTY LIMITED
K013513	DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE	Jan 17, 2002	Substantially Equivalent	PAIN CONCEPTS, INC.
K011202	MSI BIPOLAR SHEATH	Dec 31, 2001	Substantially Equivalent	MEDICAL SCIENTIFIC, INC.
K011454	SPINE SCOPE, MODEL 2180	Dec 13, 2001	Substantially Equivalent	CLARUS MEDICAL, LLC.
K013117	RESECTION ABLATOR	Nov 29, 2001	Substantially Equivalent	LINVATEC CORP.
K012630	REPROCESSED LINVATEC ARTHROSCOPIC BURS	Nov 09, 2001	Substantially Equivalent	ALLIANCE MEDICAL, INC.
K012652	REPROCESSED DYONICS ARTHROSCOPIC BURS	Nov 08, 2001	Substantially Equivalent	ALLIANCE MEDICAL CORP.
K012624	REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS	Nov 08, 2001	Substantially Equivalent	MEDICAL INSTRUMENTS TECHNOLOGY, INC.
K012635	REPROCESSED STRYKER ARTHROSCOPIC SHAVERS	Nov 07, 2001	Substantially Equivalent	ALLIANCE MEDICAL CORP.
K012613	REPROCSSED LINVATEC SHAVERS	Nov 07, 2001	Substantially Equivalent	ALLIANCE MEDICAL, INC.
K012611	REPROCESSED DYONICS ARTHROSCOPIC SHAVERS	Nov 07, 2001	Substantially Equivalent	ALLIANCE MEDICAL, INC.
K012605	REPROCESSED ATHROSCOPICS BURS	Nov 07, 2001	Substantially Equivalent	ALLIANCE MEDICAL CORP.
K012536	REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES	Nov 02, 2001	Substantially Equivalent	STERILMED, INC.
K012346	VANGUARD REPROCESSED ARTHROSCOPIC BLADES	Oct 16, 2001	Substantially Equivalent	VANGUARD MEDICAL CONCEPTS, INC.
K003198	VULCAN TAC PROBES, MODEL 911XXX	Aug 29, 2001	Substantially Equivalent	ORATEC INTERVENTIONS, INC.
K010345	KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS	Aug 03, 2001	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K003831	ARTHROSCOPES	Jul 20, 2001	Substantially Equivalent	GLOBAL ENDOSCOPY, INC.
K011083	ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND	Jun 28, 2001	Substantially Equivalent	ARTHROCARE CORP.
K010987	KSEA MINIATURE TELESCOPE AND ACCESSORIES	Jun 19, 2001	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K010811	PERC-D SPINEWAND	May 30, 2001	Substantially Equivalent	ARTHROCARE CORP.
K010677	XPS 3000 SYSTEM	May 07, 2001	Substantially Equivalent	MEDTRONIC XOMED, INC.
K003740	MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION	Apr 27, 2001	Substantially Equivalent	AESCULAP, INC.
K002088	SHAVER ABLATOR	Mar 06, 2001	Substantially Equivalent	LINVATEC CORP.
K003893	VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X	Mar 01, 2001	Substantially Equivalent	ORATEC INTERVENTIONS, INC.
K003572	DYONICS CONTROL RF SYSTEM	Feb 15, 2001	Substantially Equivalent	SMITH & NEPHEW, INC.
K010246	KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A	Feb 14, 2001	Substantially Equivalent	KYPHON, INC.
K003695	MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES	Feb 14, 2001	Substantially Equivalent	MICRO-MEDICAL DEVICES, INC.
K010179	EBI VUECATH SPINAL ENDOSCOPIC SYSTEM	Feb 09, 2001	Substantially Equivalent	EBI, L.P.
K003898	EBI VUECATH SPINAL ENDOSCOPIC SYSTEM	Jan 04, 2001	Substantially Equivalent	EBI, L.P.
K002931	METRX SYSTEM	Nov 24, 2000	Substantially Equivalent	MEDTRONIC SOFAMOR DANEK, INC.
K002764	HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR	Nov 24, 2000	Substantially Equivalent	HYDROCISION, INC.
K001741	RADIONICS RF DISC CATHETER ELECTRODE SYSTEM	Oct 23, 2000	Substantially Equivalent	RADIONICS, INC.
K002437	ENDIUS ENDOSCOPIC ACCESS SYSTEM	Oct 02, 2000	Substantially Equivalent	ENDIUS, INC.
K001918	KSEA PERCUTANEOUS FORAMINOSCOPY SET	Sep 19, 2000	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K002040	FMS SOLO	Sep 11, 2000	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K002402	VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM	Aug 31, 2000	Substantially Equivalent	MITEK PRODUCTS
K002008	SURGICAL DYNAMICS SPINAL RETRACTOR	Aug 16, 2000	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K001226	SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM	Jun 26, 2000	Substantially Equivalent	SMITH & NEPHEW, INC.
K000691	VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS	May 04, 2000	Substantially Equivalent	ORATEC INTERVENTIONS, INC.
K000198	CORTEK ARTHROSCOPE	Apr 11, 2000	Substantially Equivalent	CORTEK ENDOSCOPY, INC.
K000046	KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)	Mar 30, 2000	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K994363	INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)	Mar 06, 2000	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K994425	MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM	Feb 16, 2000	Substantially Equivalent	ENDIUS, INC.
K000153	ARTHRO-SURGIMAT-A103	Feb 08, 2000	Substantially Equivalent	W.O.M. WORLD OF MEDICINE, GMBH
K991656	AED ARTHROSCOPE	Dec 02, 1999	Substantially Equivalent	NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
K993540	ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE	Nov 22, 1999	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K993021	METRX SYSTEM	Nov 10, 1999	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K992621	ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES	Nov 08, 1999	Substantially Equivalent	ADVANCED DIAGNOSTICS & INTERVENTIONS
K992583	MASS (MICRO-ACCESS SPINE SYSTEM)	Oct 29, 1999	Substantially Equivalent	OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.
K993009	HYDROCISION ARTHROJET SYSTEM WITH CAUTERY	Oct 25, 1999	Substantially Equivalent	HYDROCISION, INC.
K990397	FLEXIBLE FIBERSCOPES & ACCESSORIES	Oct 25, 1999	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K992782	NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES	Oct 05, 1999	Substantially Equivalent	NUVASIVE, INC.
K990324	NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM	Oct 05, 1999	Substantially Equivalent	NUVASIVE, INC.
K992876	VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM	Sep 24, 1999	Substantially Equivalent	MITEK PRODUCTS
K992474	ARTHROSCOPE / MEDIFIX INC.	Sep 23, 1999	Substantially Equivalent	MEDIFIX, INC.
K991794	ENDOSCOPIC SPINAL ACCESS SYSTEM	Aug 13, 1999	Substantially Equivalent	ENDIUS, INC.
K984304	RIWO DRIVE GENERATOR	Aug 12, 1999	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K992040	FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES	Aug 06, 1999	Substantially Equivalent	FIBER IMAGING TECHNOLOGIES, INC.
K990524	E9000 SYSTEM	Jul 15, 1999	Substantially Equivalent	LINVATEC CORP.
K990911	MTP ARTHROPUMP DISPOSABLE TUBING SET	Jun 03, 1999	Substantially Equivalent	MTP MEDICAL TECHNICAL PROMOTION GMBH
K991051	KSEA EPIDUROSCOPE	Jun 01, 1999	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K990459	EBI VUECATH ENDOSCOPIC SYSTEN	Apr 23, 1999	Substantially Equivalent	ELECTRO-BIOLOGY, INC.
K983652	ABLATOR ELECTRODE	Mar 23, 1999	Substantially Equivalent	LINVATEC CORP.
K990443	ARTHRO-SURGIMAT-2000 ECU	Feb 26, 1999	Substantially Equivalent	W.O.M. WORLD OF MEDICINE, GMBH
K983144	FLEXPOSURE RETRACTOR	Feb 24, 1999	Substantially Equivalent	ENDIUS, INC.
K983142	KSEA C-MOUNT ARTHROSCOPES	Dec 07, 1998	Substantially Equivalent	KARL STORZ ENDOSCOPY
K983910	ARTHRO-SURGIMAT-1500	Nov 25, 1998	Substantially Equivalent	W.O.M. WORLD OF MEDICINE, GMBH
K983384	DCI ENDOSCOPE	Nov 25, 1998	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K983025	XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT	Nov 06, 1998	Substantially Equivalent	XOMED, INC.
K982133	OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT	Oct 22, 1998	Substantially Equivalent	THE OLYMPUS OPTICAL CO.
K982484	EBI VUECATH ENDOSCOPIC SPINAL SYSTEM	Oct 08, 1998	Substantially Equivalent	ELECTRO-BIOLOGY, INC.
K982375	STRYKER HIP ARTHOROSCOPY SET	Oct 02, 1998	Substantially Equivalent	Stryker Endoscopy
K982266	HYDROCISION ARTHROJET SYSTEM	Sep 25, 1998	Substantially Equivalent	HYDROCISION, INC.
K981636	INTEGRATED DRIVE/PUMP SYSTEM	Aug 20, 1998	Substantially Equivalent	LINVATEC CORP.
K980734	MYELOTEC VIDEO GUIDED CATHETER	Aug 11, 1998	Substantially Equivalent	MYELOTEC, INC.
K981251	KYPHON INFLATABLE BONE TAMP	Jul 02, 1998	Substantially Equivalent	KYPHON, INC.
K981269	UNIVERSAL DRIVE SYSTEM	Jun 24, 1998	Substantially Equivalent	LINVATEC CORP.
K981156	DYONICS INTELIJET INFLOW/OUTFLOW CANNULA	May 20, 1998	Substantially Equivalent	SMITH & NEPHEW, INC.
K973405	YEUNG ENDOSCOPIC SPINE SYSTEM	Mar 13, 1998	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K974579	PERCSCOPE MODEL 2600	Feb 18, 1998	Substantially Equivalent	CLARUS MEDICAL SYSTEMS, INC.
K973499	XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM	Jan 30, 1998	Substantially Equivalent	XOMED, INC.
K971781	GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES	Nov 21, 1997	Substantially Equivalent	WILSON GREATBATCH TECHNOLOGIES, INC.
K971649	KSEA ARTHROPUMP PLUS	Oct 29, 1997	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K973195	TOTAL PERFORMANCE SYSTEM SHAVER	Oct 24, 1997	Substantially Equivalent	Stryker Endoscopy
K972768	BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM	Sep 25, 1997	Substantially Equivalent	BLACKSTONE MEDICAL, INC.
K970511	DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES	Aug 12, 1997	Substantially Equivalent	SMITH & NEPHEW, INC.
K971996	MEDIVISION ARTHROSCOP	Jul 31, 1997	Substantially Equivalent	MEDIVISION SCOPE SERVICE CENTER, INC.
K971676	LIMITED REUSE ENDOSCOPIC BLADES	Jun 27, 1997	Substantially Equivalent	SMITH & NEPHEW, INC.
K971083	ARTHROSCOPE	Jun 23, 1997	Substantially Equivalent	ELECTRO-BIOLOGY, INC.
K971059	UNIVERSAL DRIVE SYSTEM	Jun 18, 1997	Substantially Equivalent	LINVATEC CORP.
K971253	VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS	Jun 13, 1997	Substantially Equivalent	SMITH & NEPHEW, INC.
K970642	TENOSCOPE	May 21, 1997	Substantially Equivalent	LUXTEC CORP.
K970562	TENOSNARE	May 14, 1997	Substantially Equivalent	LUXTEC CORP.
K970055	KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY	Mar 05, 1997	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K964879	PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM	Mar 04, 1997	Substantially Equivalent	DAVOL, INC., SUB. C.R. BARD, INC.
K964975	COHORT DISCECTOMY SYSTEMS (CDS)	Feb 24, 1997	Substantially Equivalent	COHORT MEDICAL PRODUCTS GROUP, INC.
K964919	EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM	Jan 28, 1997	Substantially Equivalent	EMERALD MEDICAL, INC.
K963304	STRYKER TEMPEST ORTHOPEDIC PUMP	Jan 22, 1997	Substantially Equivalent	Stryker Endoscopy
K962075	HSW GMBH ARTHROSCOPE	Jan 17, 1997	Substantially Equivalent	HENKE SASS WOLF OF AMERICA, INC.
K964215	ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM	Dec 20, 1996	Substantially Equivalent	SMITH & NEPHEW ENDOSCOPY, INC.
K963029	KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE	Nov 27, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K963524	KSEA LARGE JOINT ARTHROSCOPY SET	Nov 14, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY
K963332	THERMO-PLASTIC SHAVER BLADES	Oct 11, 1996	Substantially Equivalent	Stryker Endoscopy
K961228	KARL STORZ MAGNIFYING ARTHROSOCPES	Oct 10, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K961590	APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET	Oct 08, 1996	Substantially Equivalent	LINVATEC CORP.
K962330	AMO ARTHOSCOPES	Sep 11, 1996	Substantially Equivalent	AMERICAN MICROPTIKS, INC.
K960194	MYELOTEC MYELOSCOPE	Sep 04, 1996	Substantially Equivalent	MYELOTEC, INC.
K962114	ARTHRO-SURGIMAT	Aug 22, 1996	Substantially Equivalent	W.O.M. WORLD OF MEDICINE, GMBH
K962321	ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970	Jul 19, 1996	Substantially Equivalent	ARTHROCARE CORP.
K961747	ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)	Jul 15, 1996	Substantially Equivalent	ARTHROCARE CORP.
K961853	PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER	Jun 21, 1996	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K961713	INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY	May 31, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K961244	KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME	May 07, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K960805	ARTHOSCOPE	Apr 10, 1996	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K960046	SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE	Apr 02, 1996	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K960222	PERCUTANEOUS ENDOSCOPIC DISCECTOMY	Mar 08, 1996	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K954652	AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS	Feb 14, 1996	Substantially Equivalent for Some Indications	AESCULAP, INC.
K955480	BOZOTTA REINSERTION FORCEPS	Feb 09, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K955914	LIMITED REUSE ARTHROSCOPIC BLADES	Feb 08, 1996	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K955500	FMS ARTHOPROBE	Feb 05, 1996	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K954016	VIDEOSCOPE W/IRRIGATION SHEATH	Jan 25, 1996	Substantially Equivalent for Some Indications	T. KOROS SURGICAL INSTRUMENTS CORP.
K953913	OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES	Jan 22, 1996	Substantially Equivalent	OPTUS, INC.
K955652	KARL STORZ TARGETING UNIT	Jan 17, 1996	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K954964	AQUACENTER 2000 SYSTEM	Dec 28, 1995	Substantially Equivalent	AQUARIUS MEDICAL CORP.
K955471	INCL ENDOSCOPE	Dec 18, 1995	Substantially Equivalent for Some Indications	SOFAMOR DANEK USA,INC.
K954627	ECTRA II LIGAMENT RELEASE SYSTEM	Dec 18, 1995	Substantially Equivalent for Some Indications	SMITH & NEPHEW DYONICS, INC.
K955273	CANNULOC THREADED CANNULA	Dec 08, 1995	Substantially Equivalent	LINVATEC CORP.
K955272	TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY	Dec 04, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K955037	RIGID NEUROVIEW ENDOSCOPE	Dec 04, 1995	Substantially Equivalent for Some Indications	NEURO NAVIGATIONAL CORP.
K954981	KARL STORZ HEMPFLING DILATION SET	Dec 04, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K953998	DISCETOME TISSUE ASPIRATOR	Dec 04, 1995	Substantially Equivalent	T. KOROS SURGICAL INSTRUMENTS CORP.
K946087	INCLUSICE II(TM) ENDOSCOPE	Nov 21, 1995	Substantially Equivalent	SOFAMOR DANEK USA,INC.
K954882	RIZA-RIBE NEEDLE (MODIFICATION)	Nov 16, 1995	Substantially Equivalent	R-MED, INC.
K954510	RRIANGLE KNIFE	Nov 14, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954509	PROBE KNIFE	Nov 14, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954508	RETRACTOR	Nov 14, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954507	RETROGRADE KNIFE	Nov 14, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954465	FMS DUO	Nov 09, 1995	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K942029	ARTHROSCOPE	Nov 08, 1995	Substantially Equivalent	SURGICAL TECHNOLOGIES, INC.
K954052	ARTHROSCOPIC GRASPER, CUP FORCEPS AND CURETTES	Nov 06, 1995	Substantially Equivalent for Some Indications	T. KOROS SURGICAL INSTRUMENTS CORP.
K954014	PERCUTANEOUS DISCECTOMY CANNULA SYSTEM	Nov 06, 1995	Substantially Equivalent for Some Indications	T. KOROS SURGICAL INSTRUMENTS CORP.
K954440	APEX TUBING SET	Nov 02, 1995	Substantially Equivalent	LINVATEC CORP.
K954476	PROBE	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954475	BLUNT DISSECTOR, CURVED	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954464	CARPAL TUNNEL SLOTTED CANNULA	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954463	DISSECTING OBTURATOR	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954459	CONICAL OBTURATOR	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954458	BOAT NOSE OBTURATOR	Oct 23, 1995	Substantially Equivalent	PHX TECHNOLOGIES CORP.
K954217	ARTHROPLAST & ARTHRO-CUTTER	Oct 23, 1995	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K954193	SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET	Oct 23, 1995	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K953868	GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH	Sep 29, 1995	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K953659	ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)	Sep 29, 1995	Substantially Equivalent	ARTHROCARE CORP.
K930191	DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY	Sep 26, 1995	Substantially Equivalent	SOFAMOR DANEK MFG., INC.
K953695	DYONICS DISPOSABLE ARTHROSCOPIC BLADES	Sep 15, 1995	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K946174	BLOCK(TM) ARTHROSCOPIC TOOL KIT	Sep 14, 1995	Substantially Equivalent	JOHNSON
K952639	DISPOSABLE TOOTHED GRASPING FORCEP	Sep 08, 1995	Substantially Equivalent	NEURO NAVIGATIONAL CORP.
K952630	DISPOSABLE BIOPSY FORCEP	Sep 08, 1995	Substantially Equivalent	NEURO NAVIGATIONAL CORP.
K944553	PRESSURE SENSING SCOPE SHEATH SYSTEM	Sep 08, 1995	Substantially Equivalent	LINVATEC CORP.
K953484	POLLUX OA/POLLUX 30A/POLLUX 70A	Sep 01, 1995	Substantially Equivalent	POLLUX ENDOSCOPY, INC.
K953075	UNIMAT PUMP	Sep 01, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K951267	STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM	Sep 01, 1995	Substantially Equivalent	Stryker Endoscopy
K944593	STRYKER PRESSURE SENSING CANNULA	Sep 01, 1995	Substantially Equivalent	Stryker Endoscopy
K930084	MICRO-ARTHROSCOPE	Sep 01, 1995	Substantially Equivalent for Some Indications	MEDICAL DEVICES, INC.
K953550	CO2 ARTHROFLATOR	Aug 23, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K950093	AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES	Aug 15, 1995	Substantially Equivalent	SMITH & NEPHEW RICHARDS, INC.
K941862	INTEQ TFCC REPAIR SYSTEM	Aug 14, 1995	Substantially Equivalent	LINVATEC CORP.
K953387	ECTRA LIGAMENT RELEASE SYSTEM	Aug 09, 1995	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K951268	SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM	Jul 31, 1995	Substantially Equivalent	SPINE-TECH, INC.
K951624	ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM	Jul 26, 1995	Substantially Equivalent	ARGUS MEDICAL CO., INC.
K951941	CITATION MULTIPLE USE DELTA SCOPE	Jul 14, 1995	Substantially Equivalent	CITATION MEDICAL CORP.
K951843	REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT	Jul 14, 1995	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K950054	ENDO-BEND(TM) SHAVER	Jun 29, 1995	Substantially Equivalent	PALADIN MEDICAL, INC.
K945390	CITATION DELTA SCOPE	Jun 23, 1995	Substantially Equivalent	CITATION MEDICAL CORP.
K946290	CITATION POWER TOOL	Jun 15, 1995	Substantially Equivalent	CITATION MEDICAL CORP.
K951354	OLYMPUS ARTHROSCOPY SYSTEM	Jun 14, 1995	Substantially Equivalent	OLYMPUS AMERICA, INC.
K945684	POC ARTHROSCOPE AND ACCESSORIES	Jun 14, 1995	Substantially Equivalent	PRECISION OPTICS CORP.
K945787	KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES	Jun 13, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K944500	ACUFEX PATELLAR BONE BLOCK SIZER	Jun 12, 1995	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K951859	ACUFEX ENDOBUTTON PACK	Jun 09, 1995	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K945891	KARL STORZ KNIVES, CURETTS, HOOKS, PROBES	Jun 09, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K952192	KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES	Jun 08, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K951026	DAVOL ARTHRO-FLO 3	Jun 02, 1995	Substantially Equivalent	DAVOL, INC., SUB. C.R. BARD, INC.
K951163	GORE SMOOTHER GUIDED RASP	Jun 01, 1995	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K950592	ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES	Jun 01, 1995	Substantially Equivalent	EARE CONSULTING SERVICE
K943052	ARTHROSCOPIC TELESCOPES	May 25, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY
K945267	OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES	May 23, 1995	Substantially Equivalent	OPTUS, INC.
K940179	ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011	May 23, 1995	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K950242	ARGUS ARTHROSCOPY INSTRUMENT SYSTEM	May 15, 1995	Substantially Equivalent	ARGUS MEDICAL CO., INC.
K950561	KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP	May 12, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K950501	DANEK RIGID ARTHROSCOPE	May 12, 1995	Substantially Equivalent	SOFAMOR DANEK USA,INC.
K943356	INCLUSIVE ENDOSCOPE	May 10, 1995	Substantially Equivalent	DANEK MEDICAL, INC.
K950705	1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE	May 09, 1995	Substantially Equivalent	NEURO NAVIGATIONAL CORP.
K946151	BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS	May 09, 1995	Substantially Equivalent	DEPUY, INC.
K940483	2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE	May 02, 1995	Substantially Equivalent for Some Indications	NEURO NAVIGATIONAL CORP.
K950130	MICRO-ENDO(TM) INSTRUMENTS	May 01, 1995	Substantially Equivalent	SOFAMOR DANEK USA,INC.
K941188	CLARUS NEURO ENDOSCOPE (MODEL 2230)	Apr 25, 1995	Substantially Equivalent	CLARUS MEDICAL SYSTEMS, INC.
K940144	CLARUS PHOENIX ENDOSCOPE	Apr 25, 1995	Substantially Equivalent	CLARUS MEDICAL SYSTEMS, INC.
K941709	ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS	Apr 14, 1995	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K945973	FMS ARTHROSCOPY CANNULA	Mar 22, 1995	Substantially Equivalent	FUTURE MEDICAL SYSTEMS, INC.
K946313	TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER	Mar 17, 1995	Substantially Equivalent	SMITH AND NEPHEW DONJOY, INC.
K943450	ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970	Mar 13, 1995	Substantially Equivalent	ARTHROCARE CORP.
K943937	MANUAL INSTRUMENTS	Mar 06, 1995	Substantially Equivalent	PANTHEON SURGICAL PRODUCTS
K944210	ARTHROSCOPE ACCESSORIES	Feb 14, 1995	Substantially Equivalent	Stryker Endoscopy
K943426	ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE	Feb 01, 1995	Substantially Equivalent	SCHOELLY TECHNOLOGIES, INC.
K944842	ARTHROSCOPE	Jan 24, 1995	Substantially Equivalent	5 STAR MEDICAL, INC.
K941651	CTS RELIEF KIT	Jan 18, 1995	Substantially Equivalent	LINVATEC CORP.
K942298	THE KARL STORZ ARTHROPUMP	Jan 17, 1995	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K943943	TRANSTIBIAL ACL DISPOSABLES KIT	Dec 20, 1994	Substantially Equivalent	ARTHREX, INC.
K940230	ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS	Dec 12, 1994	Substantially Equivalent	INSTRATEK, INC.
K943154	KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS	Dec 06, 1994	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K943323	STRYKER SURGICAL INSTRUMENTS AND ACCESSORIES	Nov 28, 1994	Substantially Equivalent	STRYKER CORP.
K943628	ARTHROSCOPE	Nov 22, 1994	Substantially Equivalent	ELECTRO FIBEROPTICS CORP.
K940287	MENISCAL SUTURE INSTRUMENTARIUM	Nov 22, 1994	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K943676	DANEKSCOPE OPTI-PROBE	Nov 21, 1994	Substantially Equivalent	DANEK MEDICAL, INC.
K943666	ENVISION ARTHROSCOPY VISUALIZATION SYSTEM	Nov 17, 1994	Substantially Equivalent	ENVISION SURGICAL SYSTEM, INC.
K942427	ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE	Nov 17, 1994	Substantially Equivalent	ENVISION SURGICAL SYSTEM, INC.
K941333	SE5 ARTHROSCOPY SYTEM	Nov 10, 1994	Substantially Equivalent	Stryker Endoscopy
K942081	ENVISION ARTHROSCOPY SYSTEM	Nov 09, 1994	Substantially Equivalent	ENVISION SURGICAL SYSTEM, INC.
K943985	LIMITED REUSE BLADES	Nov 07, 1994	Substantially Equivalent	LINVATEC CORP.
K940847	ENDOSCOPIC PLANTAR FASCIA KIT	Oct 11, 1994	Substantially Equivalent	CITATION MEDICAL CORP.
K941718	3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD	Oct 07, 1994	Substantially Equivalent	3M MEDICAL PRODUCTS GROUP
K941388	3M FLUID IRRIGATION SYSTEM	Oct 07, 1994	Substantially Equivalent	3M HEALTH CARE
K934707	GALILEO ARTHROSCOPES	Oct 07, 1994	Substantially Equivalent	GALILEO ELECTRO-OPTICS CORP.
K940913	SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM	Oct 04, 1994	Substantially Equivalent	SPINE-TECH, INC.
K942101	4-LEAD IRRIGATION SET	Sep 30, 1994	Substantially Equivalent	DOUGLAS MEDICAL PRODUCTS CORP.
K942846	ACUFEX(R) ENDO-FEMORAL AIMER	Sep 28, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K942834	ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA	Sep 28, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K942079	MANUAL SURGICAL INSTRUMENTS	Sep 28, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K941964	LMT ARTHROSCOPIC SUTURING INSTRUMENTS	Sep 28, 1994	Substantially Equivalent	LI MEDICAL TECHNOLOGIES, INC.
K941036	CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES	Sep 28, 1994	Substantially Equivalent	SMITH & NEPHEW, INC.
K940290	ACUFEX ACL SHEATH FOR INTERFERENCE SCREWS	Sep 28, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K941273	INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER	Sep 16, 1994	Substantially Equivalent	INNOVASIVE DEVICES, INC.
K935617	ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION	Sep 16, 1994	Substantially Equivalent	DAVOL, INC., SUB. C.R. BARD, INC.
K941691	REVO ROTATOR CUFF REPAIR SYSTEM	Sep 06, 1994	Substantially Equivalent	LINVATEC CORP.
K940234	CARPAL TUNNEL SYSTEM	Aug 11, 1994	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K936280	GALILEO ARTHROSCOPES	Jul 12, 1994	Substantially Equivalent	GALILEO ELECTRO-OPTICS CORP.
K940554	TNCO, INC. ARTHROSCOPIC SURGICAL INSTRUMENTS	Jun 29, 1994	Unknown	TNCO, INC.
K940222	SMITH AND NEPHEW SPINE DEFLECTING FORCEPS	Jun 29, 1994	Substantially Equivalent for Some Indications	SMITH & NEPHEW, INC.
K932099	ACUMED FLEXIBLE CANNULA	Jun 28, 1994	Substantially Equivalent	ACUMED, INC.
K932090	ACUFEX DISPOSABLE MENISCAL CANNULA	Jun 28, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K940090	ARTHROSCOPE	Jun 03, 1994	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K940515	POLY BLADES	May 26, 1994	Substantially Equivalent	LINVATEC CORP.
K941269	GORE SMOOTHER II AND GORE BPTB	May 19, 1994	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K936213	ARTHROSCOPES AND ACCESSORIES	May 18, 1994	Substantially Equivalent	MICRO-MEDICAL DEVICES, INC.
K941364	ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS	May 16, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K940985	ACUFEX(R) ARTHROPLASTY INSTRUMENTS	May 16, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K940981	ACUFEX LINEAR/ROTARY INSTRUMENTS	May 16, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K940481	ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM	May 06, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K935221	STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS	Apr 28, 1994	Substantially Equivalent	Stryker Endoscopy
K931323	MOUNTABLE KNIFE	Apr 28, 1994	Substantially Equivalent	ESCO MEDICAL
K940623	ACUFEX SURETAC IXC SYSTEMS	Apr 26, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K940506	ACUFEX ARTHROSCOPIC SUTURE CUTTER	Apr 26, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K933576	ARTHROSCOPE, DISPOSABLE	Apr 21, 1994	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K940075	SHAVER BLADE SET	Apr 15, 1994	Substantially Equivalent	ARTHREX, INC.
K934379	LINVATEC POWERLINK SURGICAL SHAVING SYSTEM	Apr 15, 1994	Substantially Equivalent	LINVATEC CORP.
K921119	ARTHREX ARTHROSCOPE	Apr 15, 1994	Substantially Equivalent	ARTHREX, INC.
K931076	ARTHOSCOPE AND ACCESSORIES	Mar 31, 1994	Substantially Equivalent	MEDITRON DEVICES, INC.
K931109	NUCLEOTOME E KIT	Mar 29, 1994	Substantially Equivalent for Some Indications	SURGICAL DYNAMICS, INC.
K922519	MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY	Mar 29, 1994	Substantially Equivalent for Some Indications	SMITH & NEPHEW, INC.
K940454	GRASPING FORCEPS, PUNCHES, SCISSORS	Mar 25, 1994	Substantially Equivalent	LASER, INC.
K934720	AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE	Mar 25, 1994	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K934332	SURGICAL INSTRUMENTS, FORCEPS & GRASPERS, PROBES & CURETTES	Mar 25, 1994	Substantially Equivalent	FRIATEC MEDICAL INC., USA
K933470	ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM	Mar 25, 1994	Substantially Equivalent	KINETIX INSTRUMENTS
K932869	ARTHROPLANE	Mar 25, 1994	Substantially Equivalent	SYNVASIVE TECHNOLOGY, INC.
K934401	ARTHROTEK CANNULA SYSTEM	Mar 24, 1994	Substantially Equivalent	BIOMET, INC.
K933638	ACUMED CARPAL TUNNEL RELEASE KIT	Mar 24, 1994	Substantially Equivalent	ACUMED, INC.
K933070	ARTHTOTEK PRECISION HAND INSTRUMENTATION	Mar 24, 1994	Substantially Equivalent	BIOMET, INC.
K936206	GORE SMOOTHER CRUCIAL TOOL	Mar 23, 1994	Substantially Equivalent	W.L. GORE & ASSOCIATES,INC
K934181	ACUFEX ADJUSTABLE-LENGTH CANNULA	Mar 23, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K932460	ACUFEX MENISCAL RASPS	Mar 22, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K932718	ACUFEX METAL ACL CANNULA	Mar 21, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K933949	DISPOSABLE ARTHROSCOPIC ACCESSORY	Mar 18, 1994	Substantially Equivalent	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K930152	ARTHREX TIBIAL TUNNEL CANNULA	Mar 11, 1994	Substantially Equivalent	ARTHREX, INC.
K925160	ARTHRO FMS 4	Feb 17, 1994	Substantially Equivalent	ORTHOCONCEPT, INC.
K934299	DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION	Feb 14, 1994	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K934270	ACUFEX ARTHROSCOPE	Feb 14, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K926212	ARTHREX INSTRUMENTS ( HIP )	Jan 31, 1994	Substantially Equivalent	ARTHREX, INC.
K926303	ARTHREX INSTRUMENTS (WRIST)	Jan 26, 1994	Substantially Equivalent	ARTHREX, INC.
K931621	ACUFEX PRO-PAC AND ISO-PAC	Jan 21, 1994	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K923514	CLARUS SERIES 2100 ENDOSCOPE	Jan 07, 1994	Substantially Equivalent	CLARUS MEDICAL SYSTEMS, INC.
K924016	SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.	Dec 06, 1993	Substantially Equivalent	SYMBIOSIS CORP.
K922486	DANEK TISSUE CUTTING AND REMOVAL SYSTEM	Oct 12, 1993	Substantially Equivalent for Some Indications	SOFAMOR DANEK MFG., INC.
K922321	OMNI ARTHROSCOPE	Aug 03, 1993	Substantially Equivalent	EXPANDED OPTICS, INC.
K925226	SIGHT-PLUS ARTHROSCOPE	Jul 28, 1993	Substantially Equivalent	AMERICAN MEDICAL CONCEPTS, INC.
K921985	ARTHROSCOPE & ACCESSORIES	Jun 29, 1993	Substantially Equivalent	OPTIMED TECHNOLOGIES, INC.
K923069	RESTORE TUNNEL PLUG	Jun 08, 1993	Substantially Equivalent	DEPUY, INC.
K924773	BURTON H- BASE TABLE - MODEL 1990	Jun 07, 1993	Substantially Equivalent	R.H. BURTON CO.
K924494	CITSCOPE, BENDABLE -- MODIFICATION	May 26, 1993	Substantially Equivalent for Some Indications	CITATION MEDICAL CORP.
K925573	ACUFEX T-BAR	May 05, 1993	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K925083	ENDOTRAK SYSTEM	Apr 27, 1993	Substantially Equivalent	INSTRATEK, INC.
K925577	DANEK TISSUE RESECTING SYSTEM	Apr 08, 1993	Substantially Equivalent	SOFAMOR DANEK MFG., INC.
K924144	ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)	Apr 08, 1993	Substantially Equivalent	DAVOL, INC.
K911729	DANEKSCOPE AND ACCESSORIES	Apr 05, 1993	Substantially Equivalent	DANEK MEDICAL, INC.
K926193	ARTHREX INSTRUMENTS (SHOULDER GP. 1)	Mar 16, 1993	Substantially Equivalent	ARTHREX, INC.
K926111	ARTHROSCOPIC KNEE INSTRUMENTS	Mar 16, 1993	Substantially Equivalent	ARTHREX, INC.
K926062	ARTHROSCOPIC KNEE INSTRUMENTS	Mar 16, 1993	Substantially Equivalent	ARTHREX, INC.
K925996	ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES	Mar 16, 1993	Substantially Equivalent	ARTHREX, INC.
K924017	SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.	Mar 16, 1993	Substantially Equivalent	SYMBIOSIS CORP.
K925995	ARTHREX INSTRUMENTS (KNEE, GP 3)	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925986	ARTHROSCOPIC ACL DRILL SYSTEM	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925954	ARTHREX INSTRUMENTS (BASIC)	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925884	ARTHROSCOPIC RETRACTORS AND GRASPERS	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925814	ARTHREX INSTRUMENTS (BASIC)	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925458	ARTHREX RING CURETTE	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925457	ARTHREX BAYONET KNIFE	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K925456	ARTHROSCOPIC INSTRUMENTS	Mar 04, 1993	Substantially Equivalent	ARTHREX, INC.
K923525	NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR	Feb 09, 1993	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K923142	ARTHREX PLUS	Feb 09, 1993	Substantially Equivalent	ARTHREX, INC.
K925455	ARTHREX ATRAUMATIC MINI-GRASPER	Feb 08, 1993	Substantially Equivalent	ARTHREX, INC.
K922890	ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES	Feb 08, 1993	Substantially Equivalent	ARTHREX, INC.
K925437	ACUFEX CANNULATED BONE TUNNEL PLUGS	Dec 24, 1992	Substantially Equivalent	CUFEX MICROSURGICAL, INC.
K921823	ARTHREX ARTHROSCOPY ICE BLADE	Oct 15, 1992	Substantially Equivalent	ARTHREX, INC.
K922557	ACUFEX ARTHROSCOPIC CARPAL TUNNEL RELEASE KIT	Sep 17, 1992	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K920454	CLEARTRAC CANNULA	Sep 16, 1992	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K922391	ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS	Aug 18, 1992	Substantially Equivalent	INSTRATEK, INC.
K922318	DOUGLAS MEDICAL PRODUCTS, INC. IRRIGATION SET	Aug 10, 1992	Substantially Equivalent	DOUGLAS MEDICAL PRODUCTS CORP.
K922144	CITSCOPE (MODEL EXTENSIONS)	Aug 05, 1992	Substantially Equivalent	CITATION MEDICAL CORP.
K921692	INTEGRATED VIDEO SYSTEM	Jul 01, 1992	Substantially Equivalent	CITATION MEDICAL CORP.
K920800	INTEGRATED ENDOSCOPY SYSTEM 1000	Jun 30, 1992	Substantially Equivalent	BIOMET, INC.
K914963	SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET	Jun 04, 1992	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K915721	MODEL AR-6300 INFUSION PUMP	Mar 19, 1992	Substantially Equivalent	ARTHREX, INC.
K913401	SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL	Mar 06, 1992	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K914559	SMALL JOINT SYSTEM	Feb 18, 1992	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K901692	DANEK SPINALSCOPE	Feb 14, 1992	Substantially Equivalent	DANEK MEDICAL, INC.
K914282	NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER	Dec 19, 1991	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K913145	NUCLEOTOME TISSUE ASPIRATOR/CUTTER	Dec 19, 1991	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K912099	3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA	Dec 09, 1991	Substantially Equivalent	3M COMPANY
K911974	PGK STEREOTACTIC DEVICE	Nov 05, 1991	Substantially Equivalent	NORTHERN VIRGINIA RADIOLOGY AND NUCLEAR MEDICINE
K913028	ARTHRO-FLOW IRRIGATION 2 SYSTEM	Oct 10, 1991	Substantially Equivalent	DAVOL, INC.
K912957	CONCEPT MICROMILL	Oct 04, 1991	Substantially Equivalent	CONCEPT, INC.
K911296	OPTICAL CATHETER ARTHROSCOPE	Sep 24, 1991	Substantially Equivalent	MEDICAL DYNAMICS, INC.
K913347	PALMER ARCH SUPPRESSOR	Sep 18, 1991	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K912453	INTELIJET TM FLUID MANAGEMENT SYSTEM	Aug 26, 1991	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K912206	MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO.	Aug 16, 1991	Substantially Equivalent	MICROAIRE
K912205	MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO	Aug 16, 1991	Substantially Equivalent	MICROAIRE
K912871	INSIDE JOB	Aug 09, 1991	Substantially Equivalent	3M HEALTH CARE, LTD.
K912108	BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS	Jul 02, 1991	Substantially Equivalent	MICROAIRE ADVANCED SURGICAL PRODUCTS
K911205	ARTHROSCOPY INSTRUMENT CANNULA	Jun 17, 1991	Substantially Equivalent	DAVOL, INC.
K910858	STRYKER ARTHROSCOPIC INFUSION PUMP	May 23, 1991	Substantially Equivalent	STRYKER CORP.
K910587	MINISCOPE	May 13, 1991	Substantially Equivalent	CITATION MEDICAL CORP.
K910674	FLEXMEDICS MALLEABLE CANNULA	Apr 12, 1991	Substantially Equivalent	FLEXMEDICS
K911300	MICROSURGICAL INSTRUMENTS	Apr 05, 1991	Substantially Equivalent	DANEK MEDICAL, INC.
K905014	AMSET PLD SYSTEM	Apr 01, 1991	Substantially Equivalent	ADVANCED MED/SURG, INC.
K910164	ORTHOCONCEPT ARTHROSCOPIC PUMP	Mar 27, 1991	Substantially Equivalent	ORTHOCONCEPT, INC.
K905785	ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)	Mar 26, 1991	Substantially Equivalent	ORTHOCONCEPT, INC.
K904859	MOTOR DRIVEN EXTIRPATION INSTRUMENTS	Mar 15, 1991	Substantially Equivalent	AESCULAP, INC.
K904465	FLEXIBLE ARTHROSCOPE	Dec 20, 1990	Substantially Equivalent	INTRAMED LABORATORIES, INC.
K904284	ARTHROSCOPIC SURGICAL BLADE	Dec 05, 1990	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K904479	SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015	Nov 02, 1990	Substantially Equivalent	PERCUTANEOUS TECHNOLOGIES
K902778	SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER	Oct 30, 1990	Substantially Equivalent	SURGICAL DYNAMICS, INC.
K904720	POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES	Oct 26, 1990	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K900616	SHEPPERD CUTTING FORCEPS	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900615	SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900614	SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900613	SHEPPERD SHELTER TUBE COMPLETE & DRILL	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900612	SHEPPERD TREPHINE SET (GS-501-30-V)	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900611	SHEPPERD DILATATION TUBE SET (GS-501-20-H)	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900610	SHEPPERD CANNULA STILLETTE & OBDURATOR SET	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900609	SHEPPERD STRAIGHT AND CURVED NEEDLES	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K900608	SHEPPERD LUMBAR DISCECTOMY SYSTEM	Oct 22, 1990	Substantially Equivalent	DOWNS SURGICAL LTD.
K903312	CYGNASCOPE	Oct 19, 1990	Substantially Equivalent	CYGNUS INSTRUMENTS, INC.
K903620	MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM	Oct 12, 1990	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K901765	POSTEROMEDIAL GUIDE	Jun 25, 1990	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K902168	ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)	Jun 20, 1990	Substantially Equivalent	MICRO-AIRE SURGICAL INSTRUMENTS, INC.
K901735	ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444	Jun 20, 1990	Substantially Equivalent	MICRO-AIRE SURGICAL INSTRUMENTS, INC.
K901617	ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)	May 29, 1990	Substantially Equivalent	SMITH & NEPHEW, INC.
K900812	MEDICAM ARTHROSCOPE SYSTEMS	May 03, 1990	Substantially Equivalent	KIRSCHNER MEDICAL CORP.
K901505	ARTHROSCOPIC ELECTROSURGICAL PROBE	Apr 18, 1990	Substantially Equivalent	SMITH & NEPHEW DYONICS, INC.
K900680	EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS	Mar 29, 1990	Substantially Equivalent	EFFNER, INC.
K900070	MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM	Feb 16, 1990	Substantially Equivalent	DYONICS, INC.
K896678	SILICONE PLUG	Jan 30, 1990	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K896770	ARTHRODISTRACTOR	Jan 02, 1990	Substantially Equivalent	ARTHROPLASTICS, INC.
K896416	DYONICS SHOULDER PORTAL SYSTEM	Jan 02, 1990	Substantially Equivalent	DYONICS, INC.
K896584	ARTHROSCOPIC TUBING SHEATH	Dec 27, 1989	Substantially Equivalent	ORIGIN MEDSYSTEMS, INC.
K893136	SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTY	Dec 14, 1989	Substantially Equivalent	DYONICS, INC.
K896538	DISPOSABLE 45 DEGREE SHAVER	Dec 06, 1989	Substantially Equivalent	BOWEN & COMPANY, INC.
K896196	ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR	Dec 01, 1989	Substantially Equivalent	ORTHOCONCEPT, INC.
K894990	DAVOL ARTHROSCOPY CANNULA	Nov 08, 1989	Substantially Equivalent	DAVOL, INC.
K890665	MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES	Nov 03, 1989	Substantially Equivalent	DYONICS, INC.
K895685	SMALL JOINT HAND INSTRUMENTS	Oct 16, 1989	Substantially Equivalent	LEONARD MEDICAL, INC.
K894728	DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE	Aug 18, 1989	Substantially Equivalent	DYONICS, INC.
K894558	MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET	Aug 07, 1989	Substantially Equivalent	OPTIK
K892376	INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)	Aug 01, 1989	Substantially Equivalent	CONCEPT, INC.
K894303	MEDSCOPE 4MM ARTHROSCOPE	Jul 25, 1989	Substantially Equivalent	MEDSCOPE CORP.
K892062	PS3500 ARTHROSCOPIC SURGICAL SYSTEM	Jun 23, 1989	Substantially Equivalent	DYONICS, INC.
K884314	LEONARD MEDICAL 1.7MM ARTHROSCOPE	Mar 13, 1989	Substantially Equivalent	LEONARD MEDICAL, INC.
K884301	EDWARDS DISPOSABLE ARTHROSCOPY CANNULA	Mar 13, 1989	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K885183	ENDOSCOPIC LIGHT SOURCE	Mar 09, 1989	Substantially Equivalent	TECHNOLOGY FOR IMAGING, INC.
K875130	BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS	Jan 30, 1989	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K882469	CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES	Dec 01, 1988	Substantially Equivalent	ORTHOCONCEPT, INC.
K884302	EDWARDS ARTHROSCOPIC LEG HOLDER	Nov 30, 1988	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K883300	IRRIGATION SET	Nov 01, 1988	Substantially Equivalent	EDWARDS ORTHOPAEDICS DIV., BAXTER HEALTHCARE CORP.
K883361	ARTHRO-TRAC(TM)	Oct 13, 1988	Substantially Equivalent	RUDOLPH BEAVER, INC.
K881715	28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES	Aug 30, 1988	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K881703	3M CARPAL TUNNEL	Jul 25, 1988	Substantially Equivalent	3M COMPANY
K881792	CANNULA MODEL AR-6551	Jul 07, 1988	Substantially Equivalent	ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
K880295	CANNULA MODEL AR-6001	Jun 29, 1988	Substantially Equivalent	ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
K880203	HERMAN CANNULA SET	Apr 14, 1988	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K880414	TENDON HARVESTER	Mar 25, 1988	Substantially Equivalent	CONCEPT, INC.
K874911	MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG	Feb 24, 1988	Substantially Equivalent	WALTER LORENZ SURGICAL, INC.
K880331	HOOK PUNCH FORCEPS FOR ARTHROSCOPY	Feb 18, 1988	Substantially Equivalent	KIBBUTZ GILGAL MEDICAL C/O TOAM U.S.A. CORP.
K873331	ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG	Feb 17, 1988	Substantially Equivalent	DIRECTED ENERGY, INC.
K880205	EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES	Feb 04, 1988	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K873619	ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)	Jan 14, 1988	Substantially Equivalent	ARTHROPEDICS, INC.
K874515	CONCEPT SUTURE NEEDLE	Nov 27, 1987	Substantially Equivalent	CONCEPT, INC.
K873650	C-O-T SET (CANNULA, OBTURATOR AND TROCAR) #TM-1360	Nov 02, 1987	Substantially Equivalent	ARTHROPEDICS, INC.
K872533	THE CART	Nov 02, 1987	Substantially Equivalent	ARTHROPEDICS, INC.
K872986	MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT	Oct 28, 1987	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K871181	ARTHROCOMBI 5003	Sep 29, 1987	Substantially Equivalent	F.M. WIEST USA, INC.
K871180	ARTHRO AUTOMAT 5002	Sep 29, 1987	Substantially Equivalent	F.M. WIEST USA, INC.
K873030	CONCEPT ARTHROSCOPIC PORTAL ROD	Sep 16, 1987	Substantially Equivalent	CONCEPT, INC.
K872544	IRRIGATION PRESSURE MONITOR	Sep 04, 1987	Substantially Equivalent	AVEC SCIENTIFIC DESIGN CORP.
K872270	ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP	Jul 21, 1987	Substantially Equivalent	ORTHOCONCEPT, INC.
K871621	THE KARL STORZ MODEL 28805 ARTHRO PUMP	Jun 05, 1987	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K870654	EFER ARTHROSCOPE	May 14, 1987	Substantially Equivalent	ROSEBURG SA
K865066	ARTHROFLATOR	Apr 20, 1987	Substantially Equivalent	F.M. WIEST USA, INC.
K870915	SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM	Apr 01, 1987	Substantially Equivalent	C.R. BARD, INC.
K864892	ELLISON ARTHROSCOPY CHEATER	Dec 30, 1986	Substantially Equivalent	BUCKMAN CO., INC.
K864476	LEG HOLDER	Dec 15, 1986	Substantially Equivalent	AMERICAN CONTAINER TECHNOLOGY, INC.
K862017	ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT	Dec 15, 1986	Substantially Equivalent	DYONICS, INC.
K864513	LP ARTHROSCOPIC THIGH HOLDING DEVICE	Nov 25, 1986	Substantially Equivalent	TWIN FALLS ORTHOPEDIC ASSOCIATES, P.A.
K864163	HALL DUNBAR DRILL GUIDE SYSTEM	Nov 20, 1986	Substantially Equivalent	HALL SURGICAL, DIVISION OF ZIMMER, INC.
K863986	XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES	Oct 31, 1986	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K862991	LIGAMENT WASHER	Oct 29, 1986	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K862990	CANCELLOUS SCREW	Oct 29, 1986	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K863590	UNIVERSAL CANNULA SYSTEM	Oct 23, 1986	Substantially Equivalent	ASPEN LABORATORIES, INC.
K863605	ARTHROSCOPIC IRRIGATION PUMP	Oct 03, 1986	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K863597	AMERICAN EDWARDS 4.0 MM ARTHROSCOPE	Sep 25, 1986	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K863396	CONCEPT INTRAVISION ARTHROSCOPE SYSTEM	Sep 12, 1986	Substantially Equivalent	CONCEPT, INC.
K862778	HALL CANNLULA SYSTEM	Sep 08, 1986	Substantially Equivalent	HALL SURGICAL, DIVISION OF ZIMMER, INC.
K862275	ARTHROSCOPE	Aug 11, 1986	Substantially Equivalent	COMEG USA, INC.
K862658	CONCEPT ARTHROSCOPIC KNIFE	Jul 23, 1986	Substantially Equivalent	CONCEPT, INC.
K862657	CONCEPT CURETTE	Jul 23, 1986	Substantially Equivalent	CONCEPT, INC.
K861859	CABOT VIDEOSCOPE	May 30, 1986	Substantially Equivalent	CABOT MEDICAL CORP.
K861268	ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH	May 16, 1986	Substantially Equivalent	ORTHOPEDIC SYSTEMS, INC.
K860607	MARKOPTIC IMPROVED ARTHROSCOPE	Mar 05, 1986	Substantially Equivalent	MARKOPTIC
K854889	FLEX-I-GRASP	Feb 21, 1986	Substantially Equivalent	EURO-MED INTL.
K852759	AMERICAN EDWARDS LABORATORIES FLEXISCOPE	Aug 22, 1985	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K852592	CO2 FOR ARTHROSCOPY	Aug 09, 1985	Substantially Equivalent	THE ANSPACH EFFORT, INC.
K851374	AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE	Jun 28, 1985	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K851229	CODMAN ARTHROSCOPE	May 22, 1985	Substantially Equivalent	Codman & Shurtleff, Inc.
K841241	ANTERIOR CRUCIATE LIGAMENT GRASPER	Feb 06, 1985	Substantially Equivalent	SURGICAL PRODUCTS CORP.
K843604	RICHARD ARTHROSCOPE	Oct 22, 1984	Substantially Equivalent	RICHARDS MEDICAL CO., INC.
K843208	ACUFEX ARTHROSCOPE	Sep 11, 1984	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K841624	PROBE	Aug 27, 1984	Substantially Equivalent	PLASTAFIL, INC.
K841607	AMERICAN EDWARDS LABS FLEXISCOPE	Aug 18, 1984	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K842323	AMER. EDWARDS LAB FLEXISCOPE OBTURATOR	Aug 17, 1984	Substantially Equivalent	AMERICAN EDWARDS LABORATORIES
K841087	FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000	May 16, 1984	Substantially Equivalent	MACHIDA AMERICA, INC.
K834146	ANTHROSCOPY SYSTEM	Mar 08, 1984	Substantially Equivalent	CABOT MEDICAL CORP.
K834076	ARTHROSCOPIC LEG HOLDER 434-21	Dec 27, 1983	Substantially Equivalent	CUSTOM MEDICAL PRODUCTS, LTD.
K833727	CABOT ARTHROSCOPY SYSTEM	Dec 12, 1983	Substantially Equivalent	CABOT MEDICAL CORP.
K833587	DISPOSABLE ARTHROSCOPY BLADE	Nov 14, 1983	Substantially Equivalent	DYONICS, INC.
K832341	ARTHROSCOPE-VARIOUS MODELS FIBEROPTIC	Oct 04, 1983	Substantially Equivalent	KAMIYA TSUSAN KAISHA, LTD.
K832315	ARTHROSCOPY FLUID MGMT. SYSTEM	Oct 04, 1983	Substantially Equivalent	3M HEALTH CARE, SARNS
K832277	ACUFLEX LEVY ACL DRILL GUIDE SYS	Aug 16, 1983	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K831218	ARTHROSCOPY INFUSION SYS..VALVE	Jul 18, 1983	Substantially Equivalent	ACUFEX MICROSURGICAL, INC.
K831656	ARTHROSCOPY KNIVES/PROBES/BENDING TOOL	Jun 30, 1983	Substantially Equivalent	RICHARDS MANUFACTURER CO.
K831248	PATELLAR FAT PAD RETRACTOR	Jun 24, 1983	Substantially Equivalent	TECHMEDICA, INC.
K830673	CRAFON ARTHROSCOPY LINES	Jun 08, 1983	Substantially Equivalent	GAMBRO, INC.
K830499	ESA ELECTROSURGICAL ARTHROSCOPY GENERA	Mar 17, 1983	Substantially Equivalent	CONCEPT, INC.
K830120	IMPROVED ARTHROSCOPE	Mar 17, 1983	Substantially Equivalent	MARKOPTIC
K823848	CRAFTON ARTHROSCOPY PUMP AP-10	Mar 08, 1983	Substantially Equivalent	GAMBRO, INC.
K823832	ESA ARTHROSCOPY CANNULA TRAY	Feb 23, 1983	Substantially Equivalent	CONCEPT, INC.
K823499	INTRA-ARTICULAR C02 INSUFFLATOR	Jan 28, 1983	Substantially Equivalent	SURGICAL INSTRUMENT REPAIR SERVICE CO.
K821847	I.M. ARTHROSCOPE	Jul 22, 1982	Substantially Equivalent	INSTRUMENT MAKAR, INC.
K821694	ARTHROLUX ARTHROSCOPE	Jul 22, 1982	Substantially Equivalent	ARTHRO-TECH, INC.
K821672	PROFLEX	Jul 22, 1982	Substantially Equivalent	UTAH MEDICAL PRODUCTS, INC.
K821359	ARTHROSCOPES & ASSOCIATED INSTRUMENTS	May 27, 1982	Substantially Equivalent	DOWNS SURGICAL LTD.
K820777	MINI-MICRO ARTHROSCOPIC SCAPEL	May 12, 1982	Substantially Equivalent	THE ANSPACH EFFORT, INC.
K820776	CANNUOATED TROCHAR	Apr 15, 1982	Substantially Equivalent	THE ANSPACH EFFORT, INC.
K820275	ARTHROSCOPIC HARPOON	Feb 12, 1982	Substantially Equivalent	THE ANSPACH EFFORT, INC.
K820225	MENISCUS EXTRACTOR	Feb 04, 1982	Substantially Equivalent	ORTHO PARED INSTRUMENTS, INC.
K811861	ARTHROSCOPIC LEG HOLDER	Jul 16, 1981	Substantially Equivalent	STRYKER CORP.
K811675	SURGICAL INSTRUMENTS FOR USE W/ZIMMER	Jun 25, 1981	Substantially Equivalent	ZIMMER, INC.
K811596	ZIMMER ARTHROSCOPY SYSTEM	Jun 25, 1981	Substantially Equivalent	ZIMMER, INC.
K771200	ORTHOSCOPE	Jul 21, 1977	Substantially Equivalent	STRYKER CORP.
K770710	NEEDLE, SPRAY	Apr 26, 1977	Substantially Equivalent	RICHARD WOLF MEDICAL INSTRUMENTS CORP.

FEI Numbers

This FDA classification entry is associated with 368 FEI numbers. Click on an entry to view related FDA registrations.

1000036860: 18 registrations

1000112877: 433 registrations

1000112968: 424 registrations

1000116142: 15 registrations

1000120548: 6 registrations

1000120613: 66 registrations

1000123143: 29 registrations

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1000132435: 47 registrations

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1000221492: 6 registrations

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1000306139: 80 registrations

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1018470: 468 registrations

1032347: 186 registrations

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1045254: 139 registrations

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3014342096: 391 registrations

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3015173212: 285 registrations

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3015207155: 583 registrations

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3035642068: 117 registrations

3942: 32 registrations