Product Code: KNW FDA class 2 21 CFR 876.1075

Instrument, Biopsy

Gastroenterology, Urology

A Biopsy Instrument is a device used in gastroenterology, urology, and surgery to obtain tissue specimens from organs and lesions for histopathological examination, including needle, forceps, and punch biopsy configurations used endoscopically or percutaneously. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNW and it is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

View on FDA

510(k)s

361

FEI Numbers

207

Registration Numbers

207

Unique Applicants

177

Years Active

Basic Information

Product Code: KNW
Device Class: FDA class 2
Regulation Number: 876.1075
Medical Specialty: Gastroenterology, Urology
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 361 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261196	Promisemed VeriEcto Automatic Biopsy Needles	May 12, 2026	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K260365	Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char	Mar 04, 2026	Substantially Equivalent	Devicor Medical Products, Inc.
K252795	ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial	Feb 23, 2026	Substantially Equivalent	Argon Medical Devices, Inc.
K252681	EnCor EnCompass Breast Biopsy and Tissue Removal System	Dec 12, 2025	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K252183	Resitu Slider 09 (RESL09)	Sep 24, 2025	Substantially Equivalent	Resitu Medical AB
K243407	Forcyte Autograft Harvest Kit	Jul 29, 2025	Substantially Equivalent	Forcyte Medical, LLC
K244018	Disposable Biopsy Needle	Jul 22, 2025	Substantially Equivalent	Zhejiang Curaway Medical Technology Co., Ltd.
K243296	Disposable Biopsy Needle	Jul 11, 2025	Substantially Equivalent	Carbon (Shenzhen) Medical Device Co., Ltd.
K250032	Marquee Disposable Core Biopsy Instrument and Instrument Kit	Jul 10, 2025	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K243886	ExpressCore Biopsy Device	Apr 29, 2025	Substantially Equivalent	Inrad, Inc.
K243945	ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)	Apr 24, 2025	Substantially Equivalent	SurGenTec, LLC
K242128	Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)	Feb 27, 2025	Substantially Equivalent	Xaga Surgical
K242322	Bone Marrow Biopsy Needle	Jan 24, 2025	Substantially Equivalent	Zhejiang Curaway Medical Technology Co., Ltd.
K241793	Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle	Jan 24, 2025	Substantially Equivalent	Zhejiang Curaway Medical Technology Co., Ltd.
K242228	Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)	Jan 10, 2025	Substantially Equivalent	Triopsy Medical, Inc.
K243095	Mammotome AutoCore Single Insertion Core Biopsy System	Oct 29, 2024	Substantially Equivalent	Devicor Medical Products, Inc.
K242029	TRAP EASY	Oct 09, 2024	Substantially Equivalent	H.S Hospital Service S.P.A
K240664	ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)	Aug 09, 2024	Substantially Equivalent	SurGenTec, LLC
K233294	Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM	Jun 18, 2024	Substantially Equivalent	Itp Innovative Tomography Products GmbH
K233031	M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle	Jan 17, 2024	Substantially Equivalent	Canyon Medical, Inc.
K230646	SUREcore Prime Biopsy Instrument	Nov 29, 2023	Substantially Equivalent	Uro-1 Medical, Inc.
K233220	EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver (DRENCOR); EnCor MRI Breast Biopsy Driver (DRENCORMR); EnCor Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)	Oct 27, 2023	Substantially Equivalent	Senorx, Inc.
K230015	OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver	Jun 16, 2023	Substantially Equivalent	Laurane Medical Sas
K223300	Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument	Apr 21, 2023	Substantially Equivalent	Geotek Medikal Ltd Sti
K222865	M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle	Apr 03, 2023	Substantially Equivalent	Canyon Medical, Inc.
K223612	Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)	Feb 21, 2023	Substantially Equivalent	Ranfac Corporation
K222462	Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)	Jan 20, 2023	Substantially Equivalent	Itp Innovative Tomography Products GmbH
K220611	SUREcore Plus Biopsy Instrument	Dec 02, 2022	Substantially Equivalent	Uro-1, Inc.
K220595	NeoNavia Biopsy System	Sep 08, 2022	Substantially Equivalent	Neodynamics AB
K212820	Disposable Semi Automatic Biopsy Instrument	Jul 06, 2022	Substantially Equivalent	Suzhou Leapmed Healthcare Corporation
K213232	NovaCore Semi-Automatic Biopsy Instrument	Jul 01, 2022	Substantially Equivalent	Argon Medical Devices
K214063	Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle	Jun 03, 2022	Substantially Equivalent	Guangzhou Shengwei Medical Devices Co., Ltd.
K213683	Promisemed Fine Biopsy Needle	Apr 22, 2022	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K213896	BD Trek Powered Bone Biopsy System	Mar 30, 2022	Substantially Equivalent	Bard Peripheral Vascular
K212079	TeesuVac Breast Biopsy Device Mark 1	Feb 02, 2022	Substantially Equivalent	Teesuvac Aps
K213213	Arthrex Vortex Threaded Bone Marrow Recovery Needle	Nov 19, 2021	Substantially Equivalent	Arthrex, Inc.
K212284	Disposable Automatic Core Biopsy Instrument	Nov 10, 2021	Substantially Equivalent	Suzhou Leapmed Healthcare Corporation
K203141	Uramix CuraWay Biopsy Needle	Sep 17, 2021	Substantially Equivalent	Uramix, Inc.
K210946	Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles	Aug 12, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K211933	EleVation Breast Biopsy System	Jul 15, 2021	Substantially Equivalent	Bard Peripheral Vascular
K210654	EnCor Breast Biopsy Probe with Rinse Tube	Mar 31, 2021	Substantially Equivalent	Senorx, Inc.
K210631	Avitus(r) Bone Harvester	Mar 31, 2021	Substantially Equivalent	Avitus Orthopaedics, Inc.
K201650	VMCore Biopsy Needle	Jan 15, 2021	Substantially Equivalent	Uro-1, Inc.
K203397	Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm	Jan 11, 2021	Substantially Equivalent	Biopsybell S.R.L.
K202287	Ran-Flex-B Bone Marrow Aspiration Needle	Sep 18, 2020	Substantially Equivalent	Ranfac Corporation
K201166	Temno Elite Biopsy System	Aug 28, 2020	Substantially Equivalent	Merit Medical Systems, Inc.
K202012	Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System	Aug 18, 2020	Substantially Equivalent	Devicor Medical Products, Inc.
K201244	Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices	Aug 07, 2020	Substantially Equivalent	Transmed7, LLC
K192101	Medone Ultra, Medextra	Apr 02, 2020	Substantially Equivalent	Medax Srl Unipersonale
K192099	MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System	Apr 02, 2020	Substantially Equivalent	Medax Srl Unipersonale
K200278	CytoCore	Mar 31, 2020	Substantially Equivalent	Praxis Medical, LLC
K193268	APrioCore Plus	Feb 27, 2020	Substantially Equivalent	Apriomed AB
K192948	EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G	Nov 07, 2019	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K191315	Remington Medical, Inc. Automatic Cutting Needle (NAC)	Jul 12, 2019	Substantially Equivalent	Remington Medical, Inc.
K190177	J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,	Jun 12, 2019	Substantially Equivalent	Ranfac Corporation
K190378	Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix	May 24, 2019	Substantially Equivalent	Bioncise NV
K183146	Ranfac Cartilage Biopsy Needle	Apr 25, 2019	Substantially Equivalent	Ranfac Corporation
K181803	Medax Biopsy Systems III	Oct 18, 2018	Substantially Equivalent	Medax Srl Unipersonale
K171890	BEXCORE Breast Biopsy System, Biopsy Needle	Aug 20, 2018	Substantially Equivalent	Medical Park Co., Ltd.
K173316	SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device	Jun 19, 2018	Substantially Equivalent	Transmed7, LLC
K180807	Celling Aspiration Needle	May 24, 2018	Substantially Equivalent	Spine Smith Holdings, LLC
K180233	Eviva Stereotactic Guided Breast Biopsy System	Apr 10, 2018	Substantially Equivalent	Hologic, Inc.
K180450	Corvocet Biopsy System	Mar 12, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K180327	Stryker iVAS 13g Bone Biopsy Kit	Feb 26, 2018	Substantially Equivalent	Stryker Corporation
K172344	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	Nov 13, 2017	Substantially Equivalent	Medax Srl Unipersonale
K172558	iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit	Oct 05, 2017	Substantially Equivalent	Stryker Corporation
K171953	Bard Mission Disposable Core Biopsy Instrument	Sep 14, 2017	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle	Sep 11, 2017	Substantially Equivalent	Care Fusion
K162588	Möller Medical Biopsy Needles and Systems	Jun 19, 2017	Substantially Equivalent	Moller Medical GmbH
K163052	Brevera Biopsy System with Corlumina Imaging Technology	Mar 29, 2017	Substantially Equivalent	Hologic, Inc.
K170539	Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm	Mar 20, 2017	Substantially Equivalent	Avitus Orthopaedics, Inc.
K170008	Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set	Feb 28, 2017	Substantially Equivalent	Cook Incorporated
K160316	SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles	Oct 27, 2016	Substantially Equivalent	M.D.L. S.R.L.
K153709	Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet	Aug 08, 2016	Substantially Equivalent	Devicor Medical Products, Inc.
K161234	CASSI II Rotational Core Biopsy System	Aug 03, 2016	Substantially Equivalent	Scion Medical Technologies, LLC
K161409	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem	Aug 02, 2016	Substantially Equivalent	Mermaid Medical A/S
K161805	EnCor MRI Introducer Set, EnCor Probe Introducer	Jul 19, 2016	Substantially Equivalent	Senorx, Inc.
K153337	Corvocet Biopsy System	Mar 25, 2016	Substantially Equivalent	Merit Medical Systems, Inc.
K152989	Mammotome revolve Dual Vacuum Assist Biopsy System	Feb 25, 2016	Substantially Equivalent	Devicor Medical Products, Inc.
K152596	Intact® Gen2 System	Feb 15, 2016	Substantially Equivalent	Intact Medical Corporation
K152872	K2M Fenestrated Tap System	Jan 05, 2016	Substantially Equivalent	K2m
K142125	New Medax Biopsy Systems	Dec 22, 2015	Substantially Equivalent	Medax Srl Unipersonale
K153306	Imbibe Needle	Dec 18, 2015	Substantially Equivalent	Orthovita, Inc.
K152474	Avitus Bone Harvester	Oct 23, 2015	Substantially Equivalent	Avitus Orthopaedics, Inc.
K150169	Sertera Biopsy Device	Aug 14, 2015	Substantially Equivalent	Hologic, Inc.
K150088	Evacore Fully Disposable Vacuum Assist Biopsy Device	Jul 20, 2015	Substantially Equivalent	Pin-Point Care Corp.
K150625	Morrison Steerable Needle	Jun 09, 2015	Substantially Equivalent	Apriomed AB
K150563	Marrow Cellution Bone Marrow Aspiration Needle	May 22, 2015	Substantially Equivalent	Ranfac, Corp.
K141910	Intraosseous Cannula System Bio-MAC¿ and Bio-CORE	May 04, 2015	Substantially Equivalent	Biologic Therapies, Inc.
K143546	Imbibe Aspirating XIA Taps	Mar 19, 2015	Substantially Equivalent	Stryker Corporation
K142791	Spectra Soft Tissue Biopsy Needles	Jan 21, 2015	Substantially Equivalent	Spectra Medical Devices
K142377	The OnControl Bone Marrow Biopsy System by Vidacare	Dec 17, 2014	Substantially Equivalent	Vidacare, LLC
K142477	Intact Advance and Intact Excision XL, Intact BLES	Dec 15, 2014	Substantially Equivalent	Intact Medical Corporation
K140991	RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE	Sep 11, 2014	Substantially Equivalent	Ranfac, Corp.
K141552	ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS	Sep 05, 2014	Substantially Equivalent	Care Fusion
K141673	IVAS 8 GAUGE BONE BIOPSY KIT	Sep 04, 2014	Substantially Equivalent	Stryker Corporation
K133702	PRESTO BREAST BIOPSY DEVICE	Feb 28, 2014	Substantially Equivalent	Sontina Medical, LLC
K133948	BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT	Feb 21, 2014	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K130616	MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES	Feb 07, 2014	Substantially Equivalent	Biopsybell S.R.L.
K131157	RANFAC BONE MARROW ASPIRATION NEEDLE	Oct 22, 2013	Substantially Equivalent	Ranfac, Corp.
K130282	REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT	May 13, 2013	Substantially Equivalent	Remington Medical, Inc.
K123606	CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE	Mar 01, 2013	Substantially Equivalent	Scion Medical Technologies, LLC
K123259	MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM	Nov 15, 2012	Substantially Equivalent	Devicor Medical Products, Inc.
K121181	SWANNSHIDI BONE MARROW ASPIRATION NEEDLE	Aug 22, 2012	Substantially Equivalent	Alliance Partners, LLC
K120002	I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE	Jun 26, 2012	Substantially Equivalent	Busse Hospital Disposables, Inc.
K120440	PRESTO BREAST BIOPSY DEVICE	May 17, 2012	Substantially Equivalent	Sontina Medical, LLC
K112411	MAMMOTOME ELITE BIOPSY SYSTEM	Mar 20, 2012	Substantially Equivalent	Devicor Medical Products, Inc.
K113872	THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE	Mar 08, 2012	Substantially Equivalent	Vidacare Corporation
K120189	BONETRAP	Feb 22, 2012	Substantially Equivalent	Berni Farns Incorporated
K102756	SURECORE BIOPSY DEVICE	Nov 29, 2011	Substantially Equivalent	Chest Innovations, Inc.
K113209	CHIBA SONO	Nov 21, 2011	Substantially Equivalent	Pajunk GmbH
K112945	ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM	Nov 03, 2011	Substantially Equivalent	Inrad, Inc.
K112468	THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE	Oct 20, 2011	Substantially Equivalent	Regulatory Specialists, Inc.
K111765	FULL CORE BIOPSY SYSTEM	Sep 06, 2011	Substantially Equivalent	Promex Technologies, LLC
K111529	MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-	Jul 29, 2011	Substantially Equivalent	Insert Molding Solutions, Inc.
K102771	BIOPSY HANDY, MRI BIOPSY HANDY	Jun 24, 2011	Substantially Equivalent	Somatex Medical Technologies GmbH
K111100	ENCOR ENSPIRE BREAST BIOPSY SYSTEM	Jun 16, 2011	Substantially Equivalent	C.R. Bard, Inc.
K110883	J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA	Jun 08, 2011	Substantially Equivalent	Busse Hospital Disposables
K092338	MEDAX UNIPERSONALE SRL	May 27, 2011	Substantially Equivalent	Medax Unipersonale Srl
K103359	FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)	Dec 27, 2010	Substantially Equivalent	C.R. Bard, Inc.
K101832	BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT	Aug 27, 2010	Substantially Equivalent	Medical Device Technologies, Inc.
K093899	MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING	Apr 29, 2010	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K093512	ENCOR BREAST BIOPSY SYSTEM	Nov 20, 2009	Substantially Equivalent	Senorx, Inc.
K093399	PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520	Nov 19, 2009	Substantially Equivalent	Inrad
K093256	SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018	Nov 17, 2009	Substantially Equivalent	Inrad
K093068	FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US	Nov 10, 2009	Substantially Equivalent	C.R. Bard, Inc.
K092059	RP CUTTING NEEDLE	Sep 24, 2009	Substantially Equivalent	Riverpoint Medical
K090611	REVOLUTION FULL CORE BIOPSY	Jun 04, 2009	Substantially Equivalent	Inrad
K082681	VACORA VACUUM ASSISTED BIOPSY SYSTEM	Oct 15, 2008	Substantially Equivalent	C.R. Bard, Inc.
K081057	INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL	Jun 17, 2008	Substantially Equivalent	Intact Medical Corporation
K080095	CORAMATE/SPIROTOME SYSTEM	Apr 11, 2008	Substantially Equivalent	Medinvents
K080171	SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012	Mar 06, 2008	Substantially Equivalent	Sanarus Medical, Inc.
K072045	ONCONTROL BONE MARROW BIOPSY SYSTEM	Oct 22, 2007	Substantially Equivalent	Vidacare Corporation
K071814	LIGHT SABRE SPINAL ACCESS DEVICE	Oct 16, 2007	Substantially Equivalent	Minrad, Inc.
K071048	RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537	May 15, 2007	Substantially Equivalent	Rubicor Medical, Inc.
K063233	DELTACUT (APPARATUS AND CANNULA)	Apr 30, 2007	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K070091	COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208	Apr 18, 2007	Substantially Equivalent	Cardinal Health, Inc.
K063697	SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT	Feb 14, 2007	Substantially Equivalent	PAJUNK GmbH Medizintechnologie
K062832	VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138	Oct 20, 2006	Substantially Equivalent	C.R. Bard, Inc.
K060384	CORAMATE/SPIROTOME SYSTEM	Jul 13, 2006	Substantially Equivalent	Medinvents
K061570	I-STYLE BONE MARROW ASPIRATION NEEDLE	Jul 03, 2006	Substantially Equivalent	Busse Hospital Disposables, Inc.
K060413	INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE	Apr 27, 2006	Substantially Equivalent	Intact Medical Corporation
K053151	RUBICOR MAGIC BREAST BIOPSY DEVICE	Nov 18, 2005	Substantially Equivalent	Rubicor Medical, Inc.
K052638	ABBOTT SPINE, INC. SPINNAKER SYSTEM	Nov 07, 2005	Substantially Equivalent	Abbott Spine, Inc.
K052435	PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS	Nov 03, 2005	Substantially Equivalent	Pneumrx, Inc.
K052802	MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE	Nov 01, 2005	Substantially Equivalent	Manan Medical Products, Inc.
K051581	SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000	Jul 27, 2005	Substantially Equivalent	Sanarus Medical, Inc.
K051361	EASY CORE DETACHABLE BIOPSY SYSTEM	Jun 16, 2005	Substantially Equivalent	Boston Scientific Corp
K050795	IMBIBE BONE MARROW ASPIRATION NEEDLE	Jun 03, 2005	Substantially Equivalent	Orthovita, Inc.
K051158	ENCOR 7 GAUGE	May 16, 2005	Substantially Equivalent	Senorx, Inc.
K043523	INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE	Feb 11, 2005	Substantially Equivalent	Medical Device Technologies, Inc.
K042753	MAMMOTOME MR BIOPSY SYSTEM	Nov 08, 2004	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K042290	VACUUM ASSISTED CORE BIOPSY DEVICE	Oct 06, 2004	Substantially Equivalent	Suros Surgical Systems, Inc.
K042464	V-CORE FULL CORE BREAST BIOPSY INSTRUMENT	Sep 30, 2004	Substantially Equivalent	Medical Device Technologies, Inc.
K042136	SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM	Sep 08, 2004	Substantially Equivalent	Sanarus Medical, Inc.
K034021	VACUUM ASSISTED CORE BIOPSY DEVICE	Sep 08, 2004	Substantially Equivalent	Suros Surgical Systems, Inc.
K041544	COOK SIDEARM CORE TISSUE BIOPSY DEVICE	Jul 22, 2004	Substantially Equivalent	Urological, Inc.
K040266	CORE NEEDLE BIOPSY	Jul 09, 2004	Substantially Equivalent	Remington Medical, Inc.
K040842	SENORX BIOPSY DEVICE II	Apr 30, 2004	Substantially Equivalent	Senorx, Inc.
K040087	RABBIT	Apr 01, 2004	Substantially Equivalent	Scion International, Inc.
K033616	TRAPMATIC SYSTEM SET	Mar 01, 2004	Substantially Equivalent	H.S Hospital Service S.P.A
K033700	MAMMOTOME EX HAND HELD SYSTEM	Feb 20, 2004	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K032943	STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS	Dec 17, 2003	Substantially Equivalent	Stryker Corp.
K033427	MODIFICATION TO EN-BLOC BIOPSY SYSTEM	Nov 10, 2003	Substantially Equivalent	Neothermia Corp.
K032506	SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM	Oct 09, 2003	Substantially Equivalent	Sanarus Medical, Inc.
K030472	MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM	Oct 09, 2003	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K032847	EXCISOR BIOPTOME, MODEL 01-0004	Sep 26, 2003	Substantially Equivalent	Acueity, Inc.
K031344	RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE	May 23, 2003	Substantially Equivalent	Ranfac, Corp.
K030443	MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST	May 09, 2003	Substantially Equivalent	Nastech Pharmaceutical Company, Inc.
K024089	VACUFLASH BIOPSY SYSTEM	Mar 11, 2003	Substantially Equivalent	Bip USA, Inc.
K023923	SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE	Dec 11, 2002	Substantially Equivalent	Senorx, Inc.
K022286	ENCIRCLE LOCALIZATION DEVICE	Oct 11, 2002	Substantially Equivalent	Vivant Medical, Inc.
K022879	MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY	Sep 23, 2002	Substantially Equivalent	Sanarus Medical, Inc.
K020848	NAFD 100	Sep 23, 2002	Substantially Equivalent	Neomatrix, LLC
K021707	SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS	Aug 14, 2002	Substantially Equivalent	Senorx, Inc.
K022169	CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES	Jul 25, 2002	Substantially Equivalent	Parallax Medical, Inc.
K021137	SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM	Jun 26, 2002	Substantially Equivalent	Sanarus Medical, Inc.
K020987	BMN I TYPE MARROW ASPIRATION NEEDLE	Jun 25, 2002	Substantially Equivalent	H.S. Hospital Service S.R.L.
K020867	BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL	May 20, 2002	Substantially Equivalent	Worldwide Medical Technologies, LLC
K013108	BIOSUC	Apr 04, 2002	Substantially Equivalent	Hakko Medical Co., Ltd.
K020024	CARIS MINITOME BIOPSY INSTRUMENT	Apr 03, 2002	Substantially Equivalent	Artemis Medical, Inc.
K013692	TRAPSYSTEM SET	Feb 05, 2002	Substantially Equivalent	H.S. Hospital Service S.R.L.
K012088	NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT	Dec 18, 2001	Substantially Equivalent	Nastech Pharmaceutical Company, Inc.
K012023	ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE	Sep 12, 2001	Substantially Equivalent	Senorx, Inc.
K012224	SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW	Aug 22, 2001	Substantially Equivalent	Ranfac, Corp.
K011575	22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022	Aug 17, 2001	Substantially Equivalent	Imagyn Surgical
K010735	SPEEDYBELL	Aug 17, 2001	Substantially Equivalent	Biopsybell S.A.S.
K010400	VACUUM ASSISTED CORE BIOPSY DEVICE	Jul 24, 2001	Substantially Equivalent	Promex, Inc.
K011206	PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES	Jul 18, 2001	Substantially Equivalent	Parallax Medical, Inc.
K011104	OSTEOBELL	May 31, 2001	Substantially Equivalent	Biopsybell S.A.S.
K003528	SANARUS CORE TISSUE BIOPSY SYSTEM	May 03, 2001	Substantially Equivalent	Endocare, Inc.
K010037	DAUM DOUBLE-SHOOT BISOPSY GUN	Mar 22, 2001	Substantially Equivalent	Daum GmbH
K003297	MAMMOTOME HAND HELD PROBE, MODEL MHH8	Jan 18, 2001	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K003439	VIVANT BREAST LESION LOCALIZATION DEVICE	Dec 15, 2000	Substantially Equivalent	Vivant Medical, Inc.
K003370	JAMSHIDI MARROW ACQUISITION CRADLE	Nov 22, 2000	Substantially Equivalent	Allegiance Healthcare Corp.
K002546	CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE	Oct 31, 2000	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.
K001132	BONE BIOPSY NEEDLE	May 01, 2000	Substantially Equivalent	Promex, Inc.
K000612	ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE	Apr 24, 2000	Substantially Equivalent	Inrad
K000135	PRO.DUCT CATHETER, MODEL CTH03	Apr 10, 2000	Substantially Equivalent	Pro. Duct Health, Inc.
K994272	AUTOMATED CORE BIOPSY DEVICE	Jan 07, 2000	Substantially Equivalent	Promex, Inc.
K993936	15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE	Dec 27, 1999	Substantially Equivalent	Imagyn Surgical
K993342	DUCPREP BREAST ASPIRATOR, MODEL PMPO2	Dec 23, 1999	Substantially Equivalent	Windy Hill Technology, Inc.
K993435	MANUAL BONE MARROW BIOPSY DEVICE	Dec 06, 1999	Substantially Equivalent	Promex, Inc.
K992813	11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT	Nov 18, 1999	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K991980	MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,	Aug 17, 1999	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K992499	GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE	Aug 12, 1999	Substantially Equivalent	Gallini U.S., LLC
K991366	DAUM MRI/CONVENTIONAL BIOPSY KIT	Jun 25, 1999	Substantially Equivalent	Daum GmbH
K983867	FUJI CATHETER, MODEL CTH001	Jun 09, 1999	Substantially Equivalent	Windy Hill Technology, Inc.
K983296	AUTO SUTURE ABBI SYSTEM	Jun 04, 1999	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K990839	TRU-CORE I REUSABLE BIOPSY INSTRUMENT	May 20, 1999	Substantially Equivalent	Medical Device Technologies, Inc.
K990645	GALLINI ATRA-CUT NEEDLE	May 19, 1999	Substantially Equivalent	Gallini U.S., LLC
K990716	GALLINI BYCUT NEEDLE	May 17, 1999	Substantially Equivalent	Gallini U.S., LLC
K990515	MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM	May 13, 1999	Substantially Equivalent	International Medical Systems
K990782	DAUM NEUROGATE TROCAR	Apr 28, 1999	Substantially Equivalent	Daum GmbH
K990278	DAUM NEUROCUT NEUROBIOPSYNEEDLE	Mar 30, 1999	Substantially Equivalent	Daum Corp.
K983187	MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE	Dec 10, 1998	Substantially Equivalent	Medsol Corp.
K982960	MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT	Sep 23, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K982735	LIGHT SABER BONE BIOPSY NEEDLE	Sep 09, 1998	Substantially Equivalent	Minrad, Inc.
K982401	PROSTATE BIOPSY NEEDLE	Sep 08, 1998	Substantially Equivalent	Remington Medical, Inc.
K981796	LIGHT SABER CORE TISSUE NEEDLE	Aug 05, 1998	Substantially Equivalent	Minrad, Inc.
K981721	C0-AXIAL INTRODUCER NEEDLE	Jul 28, 1998	Substantially Equivalent	Inrad
K982085	MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT	Jul 17, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K981301	SPEED-CUT AUTOMATIC BIOPSY SYSTEM	Jul 08, 1998	Substantially Equivalent	Gallini U.S., LLC
K972328	PERCUTANEOUS BREAST BIOPSY (PBB)	Jul 07, 1998	Substantially Equivalent	Urothealth System, Inc.
K981320	DAUM BONE BIOPSY SET	Jun 29, 1998	Substantially Equivalent	Daum Corp.
K981166	ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214	Jun 22, 1998	Substantially Equivalent	Inrad
K981477	MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE	Jun 10, 1998	Substantially Equivalent	Medical Biopsy, Inc.
K980676	SPIGAL NEEDLE	May 21, 1998	Substantially Equivalent	Gallini U.S., LLC
K980479	QUICK-CUT AUTOMATIC BIOPSY SYSTEM	May 06, 1998	Substantially Equivalent	Gallini U.S., LLC
K963794	PUNCTURENEEDLE	Mar 19, 1998	Substantially Equivalent	Ferguson Medical
K974631	DAUM NEUROBIOPSY NEEDLE	Mar 09, 1998	Substantially Equivalent	Daum Corp.
K974576	DAUM BIOPSYGUN	Mar 06, 1998	Substantially Equivalent	Daum Corp.
K974575	DAUM ASPIRATIONBIOPSY NEEDLE	Mar 06, 1998	Substantially Equivalent	Daum Corp.
K974574	DAUM NEUROPUNCTURE NEEDLE	Mar 06, 1998	Substantially Equivalent	Daum Corp.
K980452	MANAN LIVER BIOPSY KIT	Feb 18, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980248	ACRI R NEEDLE	Feb 18, 1998	Substantially Equivalent	Gallini U.S., LLC
K980226	MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM	Feb 18, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980211	MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES	Feb 06, 1998	Substantially Equivalent	Manan Medical Products, Inc.
K980196	MD TECH BIOPSY SET FOR BONE AND BONE MARROW	Feb 03, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980122	MANAN SOFT TISSUE BIOPSY NEEDLES	Jan 30, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K974440	IBI	Jan 30, 1998	Substantially Equivalent	Gallini U.S., LLC
K980068	WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE	Jan 23, 1998	Substantially Equivalent	Worldwide Medical Technologies, LLC
K974794	WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE	Jan 23, 1998	Substantially Equivalent	Worldwide Medical Technologies, LLC
K974312	REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR	Jan 21, 1998	Substantially Equivalent	Telemed Systems, Inc.
K980004	MANAN GENERAL PURPOSE INTRODUCER NEEDLE	Jan 09, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K974814	MANAN(TM) SUPER-CORE BIOPSY NEEDLES	Jan 09, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K973152	GALLINI ABS DEVICE	Jan 09, 1998	Substantially Equivalent	Gallini U.S., LLC
K974766	MANAN TECHNA-CUT ASPIRATION NEEDLE	Jan 08, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K974446	MANAN AUTOMATIC CUTTING NEEDLE	Jan 08, 1998	Substantially Equivalent	Manan Medical Products, Inc.
K974158	ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY	Dec 09, 1997	Substantially Equivalent	Ortho Development Corp.
K972496	PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER	Dec 09, 1997	Substantially Equivalent	Tao & Tao Technologyt, Inc.
K973496	THE AUTO SUTURE* MIBB** SYSTEM	Dec 01, 1997	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K973215	STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM	Nov 06, 1997	Substantially Equivalent	Laurus Medical Corp.
K973565	QUICK-CARE BIOPSY NEEDLE	Nov 03, 1997	Substantially Equivalent	Cook, Inc.
K962977	MRI COMPATIBLE BIOPSY NEEDLES	Oct 09, 1997	Substantially Equivalent	Manan Medical Products, Inc.
K972266	GALLINI COAXIAL INTRODUCER	Jul 29, 1997	Substantially Equivalent	Gallini U.S., LLC
K970872	PAN (CHIBA ASPIRATING NEEDLE)	May 21, 1997	Substantially Equivalent	Gallini Intl., Inc.
K970871	TR NEEDLE	May 21, 1997	Substantially Equivalent	Gallini Intl., Inc.
K970565	MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)	Mar 28, 1997	Substantially Equivalent	Biopsys Medical, Inc.
K963813	SURE CORE BIOPSY KIT	Mar 20, 1997	Substantially Equivalent	Interventional Concepts, Inc.
K964777	TZ	Jan 03, 1997	Substantially Equivalent	Gallini Intl., Inc.
K963825	AUTO SUTURE* ABBI* SYSTEM	Dec 20, 1996	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K962969	MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA	Dec 06, 1996	Substantially Equivalent	Medical Device Technologies, Inc.
K961407	SPEED-CUT	Nov 21, 1996	Substantially Equivalent	Gallini Intl., Inc.
K962907	SKINNY,FRANSEEN,WESCOTT NEEDLES	Oct 23, 1996	Substantially Equivalent	Baxter Healthcare Corp
K963390	BIOPSY INTRODUCER NEEDLE	Oct 10, 1996	Substantially Equivalent	Baxter Healthcare Corp
K962077	BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER	Jul 30, 1996	Substantially Equivalent	C.R. Bard, Inc.
K960065	TEMNO DOUBLE SHOT BIOPSY NEEDLE	Apr 05, 1996	Substantially Equivalent	Bauer Medical, Inc.
K960064	TEMNO ACHIEVE BIOPSY NEEDLE	Apr 05, 1996	Substantially Equivalent	Bauer Medical, Inc.
K960509	18 GAUGE TRU-CUT BIOPSY NEEDLE	Apr 04, 1996	Substantially Equivalent	Baxter Healthcare Corp
K954999	LILY MULTICANNULA GUIDE	Apr 04, 1996	Substantially Equivalent	Lily Imaging Solutions Co.
K954529	AUTOMATED TRU-CUT BIOPSY DEVICE	Dec 29, 1995	Substantially Equivalent	Baxter Healthcare Corp
K953399	NEEDLE OR CUTTER	Oct 30, 1995	Substantially Equivalent	Biophysic Medical, Inc.
K954265	TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE	Sep 29, 1995	Substantially Equivalent	Promex, Inc.
K954151	BIOACCESS BONE BIOPSY SYSTEM	Sep 15, 1995	Substantially Equivalent	Bioaccess, Inc.
K953923	URESIL INTRODUCING NEEDLE	Sep 08, 1995	Substantially Equivalent	Uresil Corp.
K953880	BIOPSY NEEDLE	Sep 08, 1995	Substantially Equivalent	Biopsys Medical, Inc.
K951229	MODIFIED BIOPSY NEEDLE	Apr 06, 1995	Substantially Equivalent	Biopsys Medical, Inc.
K950732	MANAN SUPER-CORE BIOPSY NEEDLE	Mar 02, 1995	Substantially Equivalent	Manan Medical Products, Inc.
K945573	BIOPSY DEVICE ACCESSORY	Dec 09, 1994	Substantially Equivalent	Biopsys Medical, Inc.
K944837	MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE	Oct 14, 1994	Substantially Equivalent	Medical Device Technologies, Inc.
K943651	TECHNA-CUT ASPIRATION NEEDLE	Sep 29, 1994	Substantially Equivalent	Manan Medical Products, Inc.
K943650	LIVER BIOPSY KIT	Aug 26, 1994	Substantially Equivalent	Manan Medical Products, Inc.
K943368	TRU-CORE NEEDLE SET	Jul 29, 1994	Substantially Equivalent	Ideamatrix
K941256	QUICK CORE II	Jul 13, 1994	Substantially Equivalent	Proact, Ltd.
K942630	WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE	Jul 12, 1994	Substantially Equivalent	Mill-Rose Laboratory
K942639	BIOPSY NEEDLE AND HOUSING	Jul 07, 1994	Substantially Equivalent	Biopsys Medical, Inc.
K934371	BIP MULTI MODIFICATION	Apr 28, 1994	Substantially Equivalent	Bip USA, Inc.
K941549	BIOPSY NEEDLE AND HOUSING	Apr 19, 1994	Substantially Equivalent	Biopsys Medical, Inc.
K935814	MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE	Mar 14, 1994	Substantially Equivalent	Boston Scientific Corp
K940365	MANAN ADAPTER FOR BARD BIOPTY SYSTEM	Feb 25, 1994	Substantially Equivalent	Manan Medical Products, Inc.
K933448	MANAN ADAPTER FOR BIP BIOPSY DEVICE	Nov 12, 1993	Substantially Equivalent	Manan Medical Products, Inc.
K930201	ACECUT SUTOMATIC BIOPSY SYSTEM	Jun 09, 1993	Substantially Equivalent	Meadox Surgimed, Inc.
K930083	EMS BIOPSY INSTRUMENT	Apr 21, 1993	Substantially Equivalent	Engineered Medical Systems
K930241	OLYMPUS DISPOSABLE BIOPSY FORCEPS	Apr 20, 1993	Substantially Equivalent	Olympus Corp.
K922939	BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.	Feb 16, 1993	Unknown	C.R. Bard, Inc.
K924106	BIOPSY FORCEPS	Nov 24, 1992	Substantially Equivalent	United States Endoscopy Group, Inc.
K922161	GRICE SOFT TISSUE BIOPSY KIT	Oct 13, 1992	Substantially Equivalent	Ideal Medical, Inc.
K922879	MEADOX SURGIMED BIOPSY GUN III	Sep 01, 1992	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K914215	SELECTACUT BIOPSY DEVICE	Feb 24, 1992	Substantially Equivalent	Biomni Medical Systems, Inc.
K914874	MANAN PRO-MAG AUTOMATIC BIOPSY DEVICE	Feb 18, 1992	Substantially Equivalent	Manan Medical Products, Inc.
K912892	AUTO-VAC BIOPSY NEEDLE	Feb 07, 1992	Substantially Equivalent	Angiomed GmbH & Co. Medizintechnik KG
K913098	APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501	Nov 05, 1991	Substantially Equivalent	Dlp, Inc.
K910190	BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT	Aug 16, 1991	Unknown	C.R. Bard, Inc.
K911635	MEADOX(R) SURGIMED(R) BIOPSY GUN II	Jun 20, 1991	Substantially Equivalent	Meadox Surgimed, Inc.
K905557	CCC CROWN-CORE-CUT-NEEDLE	Mar 08, 1991	Substantially Equivalent	Uni-Quatro Industries Canada, Inc.
K904987	VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)	Feb 11, 1991	Substantially Equivalent	Vibronics
K904658	AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY ASPIR. DEV	Nov 20, 1990	Substantially Equivalent	Leigh Med Tech, Inc.
K902066	DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES	Sep 06, 1990	Substantially Equivalent	Endo-Scientific, Inc.
K902077	T19S BIOPSY NEEDLE	Jul 27, 1990	Substantially Equivalent	Ohio Medical Instrument Co., Inc.
K902461	MEADOX SURGIMED BIOPSY GUN AND NEEDLE	Jul 16, 1990	Substantially Equivalent	Meadox Surgimed, Inc.
K900082	MAXX 470 CORE BIOPSY GUN	Jun 27, 1990	Substantially Equivalent	Dlp, Inc.
K896933	INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN	Jun 22, 1990	Substantially Equivalent	The Witmoore Group, Inc.
K901339	BIOPSY FORCEPS (NON-RIGID)	Jun 11, 1990	Substantially Equivalent	Applied Medical Technologies
K895457	MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES	Nov 01, 1989	Substantially Equivalent	Advance Medical Designs, Inc.
K894419	GASTRO ENTEROLOGICAL BIOPTOME	Sep 08, 1989	Substantially Equivalent	Symbiosis Corp.
K893992	NOETIX, BIOPSY NEEDLE	Sep 08, 1989	Substantially Equivalent	Noetix, Inc.
K892071	GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE	Aug 08, 1989	Substantially Equivalent	Amedic USA
K882746	ADMS SILENT NEEDLE GUN	Mar 17, 1989	Substantially Equivalent	Advanced Diagnostic Medical Systems, Inc.
K885169	STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE	Feb 27, 1989	Substantially Equivalent	Boston Scientific Corp
K884900	SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER	Jan 13, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K883469	BARD(R) ASPIRATION BIOPSY SYSTEM	Jan 06, 1989	Substantially Equivalent	C.R. Bard, Inc.
K883884	PROSTATIC CORE-CUT NEEDLE	Dec 05, 1988	Substantially Equivalent	Euro-Med Intl.
K883374	BARD BIOPSY NEEDLE GUIDANCE DEVICE	Sep 29, 1988	Substantially Equivalent	C.R. Bard, Inc.
K881957	HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT	May 20, 1988	Substantially Equivalent	N-S Medical Products
K881956	NATIONAL-STANDARD NEEDLE HOLDER	May 20, 1988	Substantially Equivalent	N-S Medical Products
K880098	VAN-TEC AUTO BIOPSY NEEDLE	Mar 02, 1988	Substantially Equivalent	Van-Tec, Inc.
K880096	VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP	Mar 02, 1988	Substantially Equivalent	Van-Tec, Inc.
K874062	ENTERON LIVER BIOPSY TRAY	Dec 31, 1987	Substantially Equivalent	Endovations
K873996	CAREY CAPSULE	Dec 29, 1987	Substantially Equivalent	Wilson-Cook Medical, Inc.
K874314	WILSON-COOK BIOPSY FORCEPS	Dec 07, 1987	Substantially Equivalent	Wilson-Cook Medical, Inc.
K873369	SECURLINE FRANSEENE NEEDLE	Oct 20, 1987	Substantially Equivalent	Precision Dynamics Corp.
K873208	MANAN TURNER STYLE NEEDLE	Aug 25, 1987	Substantially Equivalent	Manan Manufacturing Co., Inc.
K871390	BARD BIOPTY BIOPSY SYSTEM	Jun 05, 1987	Substantially Equivalent	C.R. Bard, Inc.
K870785	SOFT TISSUE BIOPSY NEEDLE	Apr 01, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870735	PROSTATIC ASPIRATION BIOPSY SET	Mar 25, 1987	Substantially Equivalent	Van-Tec, Inc.
K870734	TEFLON BIOPSY CATHETER W/TIP ANGLE	Mar 10, 1987	Substantially Equivalent	Van-Tec, Inc.
K861267	UROCUT BIOPSY NEEDLE	Jan 20, 1987	Substantially Equivalent	Meadox Surgimed, Inc.
K864329	MODELS 54601/54602/54603/54604 NEEDLE & BIOPSY KIT	Dec 03, 1986	Substantially Equivalent	Dlp, Inc.
K862562	PUNCH BIOPSY KIT	Oct 07, 1986	Substantially Equivalent	Clinipad Corp.
K861959	BMRI SOFT TISSUE BIOPSY NEEDLE	Sep 23, 1986	Substantially Equivalent	Bio-Medical Resources, Inc.
K855003	BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732	Feb 10, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K854297	MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM	Nov 26, 1985	Unknown	Medsurg Industries, Inc.
K854291	MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY	Nov 26, 1985	Substantially Equivalent	Medsurg Industries, Inc.
K850605	RADI-BIOPSY DEVICE	Aug 09, 1985	Substantially Equivalent	Radiplast AB
K851839	MANAN MADAYAG PTC NEEDLE	Jun 21, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851838	MANAN CHIBA PTC NEEDLE	Jun 21, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851836	MANAN MENGHINI NEEDLE	Jun 21, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851798	53-160 TO 53-167 VARIOUS BIOPSY FORCEPS YEOMAN	May 23, 1985	Substantially Equivalent	Artiberia
K851835	MANAN GREENE NEEDLE	May 17, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851837	MANAN WESTCOTT NEEDLE	May 14, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851831	MANAN FRANSEENE NEEDLE	May 14, 1985	Substantially Equivalent	Manan Manufacturing Co., Inc.
K851364	FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP	Apr 22, 1985	Substantially Equivalent	Precision Dynamics Corp.
K850438	RENAL BIOPSY TRAY	Feb 26, 1985	Substantially Equivalent	Packaging Technologies, Inc.
K820293	BONE BIOPSY SET	Mar 01, 1982	Substantially Equivalent	The Anspach Effort, Inc.
K813462	MADAYAG TYPE NEEDLE	Mar 01, 1982	Substantially Equivalent	Ocean Medical Products, Ltd.
K813085	HEPAFIX BIOPSY NEEDLE SET	Nov 20, 1981	Substantially Equivalent	Burron Medical Products, Inc.
K811454	VANCE PROSTATIC ASPIRATION SET	Jun 09, 1981	Substantially Equivalent	Vance Products, Inc.
K781038	HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM	Aug 14, 1978	Substantially Equivalent	Quinton, Inc.
K770122	PROSTATE BIOPSY NEEDLE	Jan 26, 1977	Substantially Equivalent	Cook, Inc.
K760868	VEST RESTRAINT	Nov 01, 1976	Substantially Equivalent	Orthopedic Equipment Co., Inc.