Product Code: GDW FDA class 2 21 CFR 878.4750

Staple, Implantable

General, Plastic Surgery

The Staple, Implantable (product code GDW) is a surgically placed metallic staple designed to remain inside the body after a procedure, used to approximate or secure internal tissues, organs, or anastomoses in general or plastic surgery. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The device is regulated under 21 CFR 878.4750 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is intended for permanent or long-term placement within the body.

View on FDA

510(k)s

283

FEI Numbers

136

Registration Numbers

136

Unique Applicants

Years Active

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Basic Information

Product Code: GDW
Device Class: FDA class 2
Regulation Number: 878.4750
Medical Specialty: General, Plastic Surgery
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 283 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260196	ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)	May 11, 2026	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K253657	Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads	Apr 10, 2026	Substantially Equivalent	Covidien (Part of Medtronic)
K252739	ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)	Dec 17, 2025	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K250835	ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)	May 14, 2025	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K243276	ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON LINEAR Stapler 90mm Stapler (GTX90); ECHELON LINEAR Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR Stapler 3D 90mm Green Reload (GTXR90G)	Feb 25, 2025	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K241630	ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)	Oct 28, 2024	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K242679	Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)	Oct 04, 2024	Substantially Equivalent	Fengh Medical Co., Ltd.
K222487	Anika Tissue Tack Fixation System	May 08, 2023	Substantially Equivalent	Anika Therapeutics, Inc.
K222210	AEON Endoscopic Stapler	Apr 21, 2023	Substantially Equivalent	Lexington Medical, Inc.
K223760	ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cutter (GLC100);ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR Cutters 100mm Green Reload (GLCR100G)	Mar 15, 2023	Substantially Equivalent	Ethicon Endo-Surgery
K211197	Disposable Endoscopic Cutter Stapler and Cartridge	Jan 19, 2023	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.
K221771	EEA Circular Stapler with Tri-Staple Technology	Nov 30, 2022	Substantially Equivalent	Covidien
K222641	Signia Small Diameter Reloads Including Regular (Round) Tip Version	Nov 29, 2022	Substantially Equivalent	Covidien
K221003	Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA	Sep 30, 2022	Substantially Equivalent	Covidien
K221013	GIA Auto Suture Stapler with DST Series Technology	May 05, 2022	Substantially Equivalent	Covidien
K221006	GIA Stapler with Tri-Staple Technology	Apr 29, 2022	Substantially Equivalent	Covidien
K221005	EEA Circular Stapler with Tri-Staple Technology	Apr 29, 2022	Substantially Equivalent	Covidien
K211811	Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers	Mar 03, 2022	Substantially Equivalent	Wuxi Beien Surgery Device Co., Ltd.
K211458	Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers	Dec 30, 2021	Substantially Equivalent	Ningbo Verykind Medical Device Co., Ltd.
K201934	Surgimatix Absorbable Fixation System	Oct 01, 2021	Substantially Equivalent	Surgimatix, Inc.
K210909	easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use	Jun 24, 2021	Substantially Equivalent	Ezisurg Medical Co., Ltd.
K201639	Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads	May 27, 2021	Substantially Equivalent	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
K202709	Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges	May 18, 2021	Substantially Equivalent	Ningbo Verykind Medical Device Co., Ltd.
K210278	Titan SGS	Apr 28, 2021	Substantially Equivalent	Standard Bariatrics
K200320	Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload	Feb 05, 2021	Substantially Equivalent	M/s. Meril Endo Surgery Private Limited.
K202507	EEA Circular Stapler with Tri-Staple Technology	Jan 21, 2021	Substantially Equivalent	Covidien
K203117	TissueTak device	Jan 07, 2021	Substantially Equivalent	Via Surgical , Ltd.
K202467	Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads	Dec 14, 2020	Substantially Equivalent	Fengh Medical Co., Ltd.
K202701	GIA Stapler with Tri-Staple Technology	Dec 07, 2020	Substantially Equivalent	Covidien
K202864	Tri-Staple 2.0 Reloads	Oct 28, 2020	Substantially Equivalent	Covidien
K202665	Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm	Oct 15, 2020	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K201882	AEON Endoscopic Stapler	Oct 09, 2020	Substantially Equivalent	Lexington Medical, Inc.
K201280	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed	Jul 27, 2020	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K201672	Signia Stapler (with new software)	Jul 17, 2020	Substantially Equivalent	Covidien
K200420	Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green	Jun 29, 2020	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K192720	GIA Stapler with Tri-Staple Technology	Mar 13, 2020	Substantially Equivalent	Covidien
K192330	EEA Circular Stapler with Tri-Staple Technology	Jan 23, 2020	Substantially Equivalent	Covidien
K190884	TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool	Dec 26, 2019	Substantially Equivalent	Datascope Corp.
K182476	Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads	Dec 18, 2019	Substantially Equivalent	Fengh Medical Co., Ltd.
K190331	Applied Medical Laparoscopic Linear Cutter	Nov 22, 2019	Substantially Equivalent	Applied Medical Resources Corporation
K192566	Reach and CQ'ENCE Circular Staplers	Oct 17, 2019	Substantially Equivalent	Reach Surgical, Inc.
K191070	Signia Small Diameter Reloads	Sep 04, 2019	Substantially Equivalent	Covidien
K191287	OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners	Jul 16, 2019	Substantially Equivalent	Davol Inc., Subsidiary of C.R. Bard
K182217	Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use	Apr 16, 2019	Substantially Equivalent	Ezisurg (Suzhou) Medical Co., Ltd.
K182475	Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)	Mar 14, 2019	Substantially Equivalent	Covidien
K181668	FasTouch Absorbable Fixation System	Mar 13, 2019	Substantially Equivalent	Via Surgical , Ltd.
K183477	easyPPHTM Hemorrhoidal Stapler for Single Use	Feb 11, 2019	Substantially Equivalent	Ezisurg Medical Co., Ltd.
K183435	Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black	Feb 06, 2019	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K181657	easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use	Feb 01, 2019	Substantially Equivalent	Ezisurg Medical Co., Ltd.
K180175	SignalMark Lung Biopsy Site Marker	Dec 07, 2018	Substantially Equivalent	View Point Medical, Inc.
K182380	AEON Endoscopic Stapler	Nov 28, 2018	Substantially Equivalent	Lexington Medical, Inc.
K181653	Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed	Sep 18, 2018	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K181620	Endoscopic Linear Cutting Staplers and Loading Units for Single Use	Sep 18, 2018	Substantially Equivalent	Ezisurg (Suzhou) Medical Co., Ltd.
K173270	Tri-Staple 2.0 Reinforced Reload	Feb 20, 2018	Substantially Equivalent	Covidien
K172361	EEA Circular Stapler with Tri-Staple Technology	Feb 16, 2018	Substantially Equivalent	Covidien
K173443	AEON Endoscopic Stapler	Feb 01, 2018	Substantially Equivalent	Lexington Medical, Inc.
K172960	easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use	Dec 21, 2017	Substantially Equivalent	Ezisurg Medical Co., Ltd.
K172561	Disposable Circular Stapler	Dec 05, 2017	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.
K172538	Disposable Linear Stapler, Disposable Linear Cutter	Nov 30, 2017	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.
K171589	AEON Endoscopic Stapler	Nov 17, 2017	Substantially Equivalent	Lexington Medical, Inc.
K171561	Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload	Aug 28, 2017	Substantially Equivalent	Dextera Surgical, Inc.
K162707	Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload	Jul 14, 2017	Substantially Equivalent	Golden Stapler Surgical Co., Ltd.
K170278	OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners	May 31, 2017	Substantially Equivalent	C.R. Bard, Inc.
K163523	ECHELON CIRCULAR Powered Stapler	Apr 18, 2017	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K163698	OptiFix Open Absorbable Fixation System - 20 absorbable fasteners	Apr 11, 2017	Substantially Equivalent	C.R. Bard, Inc.
K162947	Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler	Mar 03, 2017	Substantially Equivalent	Chongqing Qmi Surgical Co., Ltd.
K170348	Signia Four-Bay Smart Charger (to be used with Signia Stapler)	Mar 02, 2017	Substantially Equivalent	Covidien
K162710	Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload	Feb 09, 2017	Substantially Equivalent	Tgs Medical Co., Ltd.
K163454	ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm	Jan 05, 2017	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K160969	ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler	Dec 12, 2016	Substantially Equivalent	Shinemed, LLC
K163098	Tri-Staple 2.0 Intelligent Cartridge	Dec 05, 2016	Substantially Equivalent	Covidien, LLC
K161757	Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads	Dec 05, 2016	Substantially Equivalent	Victor Medical Instruments Co., Ltd.
K161905	Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge	Nov 17, 2016	Substantially Equivalent	Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
K162252	FasTouch Fixation System	Nov 14, 2016	Substantially Equivalent	Via Surgical , Ltd.
K161137	Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload	Jul 20, 2016	Substantially Equivalent	Cardica, Inc.
K160900	CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners	May 31, 2016	Substantially Equivalent	C.R. Bard, Inc.
K160176	Signia Stapler	Apr 26, 2016	Substantially Equivalent	Covidien
K153202	iMESH Tacker	Mar 24, 2016	Substantially Equivalent	Thd Lap
K160521	ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm	Mar 22, 2016	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K151081	MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge	Jan 15, 2016	Substantially Equivalent	Cardica, Inc.
K152618	PANTHER Cutter Stapler	Nov 12, 2015	Substantially Equivalent	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
K151659	ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks	Jul 17, 2015	Substantially Equivalent	Covidien, LLC
K142577	PANTHER Endo Linear Cutter Staplers with Single Use Loading Units	Jun 11, 2015	Substantially Equivalent	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
K151163	Signia Loading Unit, Tri-Staple 2.0 Cartridge	May 29, 2015	Substantially Equivalent	Covidien, LLC
K150026	Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler	May 18, 2015	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K142873	OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners	Mar 12, 2015	Substantially Equivalent	C.R. Bard, Inc.
K142808	CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners	Mar 09, 2015	Substantially Equivalent	C.R. Bard, Inc.
K143129	easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)	Jan 29, 2015	Substantially Equivalent	Ezisurg Medical Co., Ltd.
K141952	ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED	Nov 24, 2014	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K141097	CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE	Sep 26, 2014	Substantially Equivalent	Touchstone International Medical Science Co., Ltd.
K141367	LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS	Jul 25, 2014	Substantially Equivalent	Touchstone International Medical Science Co., Ltd.
K140560	ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING	Apr 22, 2014	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K140609	RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS	Apr 09, 2014	Substantially Equivalent	Covidien
K131563	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	Apr 09, 2014	Substantially Equivalent	Opus Ksd, Inc.
K132698	FASTOUCH FIXATION SYSTEM	Mar 14, 2014	Substantially Equivalent	Via Surgical , Ltd.
K140118	MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE	Feb 25, 2014	Substantially Equivalent	Cardica, Inc.
K140170	MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE	Feb 19, 2014	Substantially Equivalent	Cardica, Inc.
K132472	JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD	Feb 11, 2014	Substantially Equivalent	Justright Surgical, LLC
K133938	ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY	Jan 22, 2014	Substantially Equivalent	Covidien
K133499	SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA	Jan 14, 2014	Substantially Equivalent	Suzhou Beinuo Medical Equipment Co. , Ltd.
K132669	PROXIFAST ABSORBABLE STAPLE	Jan 13, 2014	Substantially Equivalent	Surgimatix, Inc.
K133762	ENDO GIA(TM) EXTRA LONG ADAPTER	Jan 08, 2014	Substantially Equivalent	Covidien, LLC
K132581	MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE	Jan 07, 2014	Substantially Equivalent	Cardica, Inc.
K130738	ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS	Dec 13, 2013	Substantially Equivalent	Nanjing Maidixin Medical Device Co., Ltd.
K132134	OPTIFIX ABSORBABLE FIXATION SYSTEM	Dec 02, 2013	Substantially Equivalent	C.R. Bard, Inc.
K132493	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	Oct 23, 2013	Substantially Equivalent	Covidien, LLC
K131663	ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK	Oct 18, 2013	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K131637	ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)	Jul 12, 2013	Substantially Equivalent	Rotation Medical, Inc.
K131511	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR	Jul 05, 2013	Substantially Equivalent	Changzhou Sinolinks Medical Innovation Co., Ltd.
K131705	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	Jul 01, 2013	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K131303	DISPOSABLE CIRCULAR STAPLER	Jun 11, 2013	Substantially Equivalent	Changzhou City Zhiye Medical Devices Institute Co.
K130717	ENDO GIA RELOAD	Apr 18, 2013	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K130653	ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU	Mar 29, 2013	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K123114	ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE	Feb 05, 2013	Substantially Equivalent	ETHICON, Inc.
K122781	RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD	Feb 05, 2013	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K123718	PERMASORB DISPOSABLE FIXATION DEVICE	Jan 22, 2013	Substantially Equivalent	C.R. Bard, Inc.
K123318	IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER	Dec 18, 2012	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K123109	ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE	Oct 23, 2012	Substantially Equivalent	Covidien
K121510	IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER	Jul 25, 2012	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K121600	ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE	Jul 16, 2012	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K121474	DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER	Jul 16, 2012	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.
K120179	REACH SURGICAL STAPLERS	May 23, 2012	Substantially Equivalent	Reach Surgical, Inc.
K120373	INSORB ABSORBALBE STAPLE	Mar 16, 2012	Substantially Equivalent	Incisive Surgical, Inc.
K120258	DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS	Feb 29, 2012	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K120268	AMID STAPLER	Feb 10, 2012	Substantially Equivalent	Safestich Medical, LLC
K112056	ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL	Dec 19, 2011	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K111825	ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS	Oct 25, 2011	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K111195	VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS	Aug 03, 2011	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K111111	ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO	Jun 08, 2011	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K110728	IMESH TACKER	Jun 08, 2011	Substantially Equivalent	Easylap , Ltd.
K111153	SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM	May 24, 2011	Substantially Equivalent	C.R. Bard, Inc.
K111064	TIGERPAW SYSTEM II	May 18, 2011	Substantially Equivalent	Laax, Inc.
K103672	REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET	Apr 08, 2011	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K110385	ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER	Mar 25, 2011	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K110049	REUSABLE LINEAR STAPLER HANDLE	Feb 10, 2011	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K103470	PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP	Jan 11, 2011	Substantially Equivalent	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
K103263	ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY	Nov 22, 2010	Substantially Equivalent	Covidien, Formerly US Surgical A Divison of Tyco H
K101961	TIGERPAW SYSTEM	Oct 29, 2010	Substantially Equivalent	Laax, Inc.
K102325	IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)	Oct 13, 2010	Substantially Equivalent	Covidien, LLC, Formerly Registered AS Tyco Healthca
K102632	ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER	Oct 07, 2010	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K102291	COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	Sep 15, 2010	Substantially Equivalent	Covidien
K101378	FRANKENMAN SURGICAL STAPLERS	Jun 29, 2010	Substantially Equivalent	Suzhou Frankenman Medical Equipment Co., Ltd.
K101444	AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY	Jun 14, 2010	Substantially Equivalent	Surgical Devices, A Global Business Unit Tyco
K100723	DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5	Apr 30, 2010	Substantially Equivalent	Changzhou Kangdi Medical Stapler Co., Ltd.
K093845	ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25	Apr 07, 2010	Substantially Equivalent	ETHICON, Inc.
K100386	DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32	Mar 01, 2010	Substantially Equivalent	Changzhou Waston Medical Appliance Co., Ltd.
K092483	BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018	Dec 18, 2009	Substantially Equivalent	C.R. Bard, Inc.
K093410	AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY	Nov 12, 2009	Substantially Equivalent	Surgical Devices, A Divsion of Tyco Healthcare
K093402	AUTOSUTURE EEA ORVIL	Nov 12, 2009	Substantially Equivalent	Surgical Devices, A Global Business Unit Tyco
K093253	AMID STAPLER	Nov 12, 2009	Substantially Equivalent	Safestitch, LLC
K092577	ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)	Sep 15, 2009	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K091900	ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE	Jul 16, 2009	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States
K090821	CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L	Jun 10, 2009	Substantially Equivalent	Frankenman International Limited
K091322	CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G	Jun 01, 2009	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K091215	INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT	May 18, 2009	Substantially Equivalent	Power Medical Interventions, Inc.
K083519	AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS	Apr 10, 2009	Substantially Equivalent	Covidien Lp, Formerly Registered AS United States
K090159	INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES	Feb 06, 2009	Substantially Equivalent	Incisive Surgical, Inc.
K083781	EEA HEMORRHOID STAPLER & ACCESSORIES	Feb 04, 2009	Substantially Equivalent	Surgical Devices, A Global Business Unit Covidien
K082396	DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087	Jan 02, 2009	Substantially Equivalent	C.R. Bard, Inc.
K083527	INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS	Dec 18, 2008	Substantially Equivalent	Power Medical Interventions, Inc.
K071023	REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C	Aug 28, 2008	Substantially Equivalent	Reach Surgical, Inc.
K081826	INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V	Jul 25, 2008	Substantially Equivalent	Power Medical Interventions, Inc.
K080972	ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP	Jul 03, 2008	Substantially Equivalent	Ethicon Endo-Sugery, LLC
K081146	ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)	Jun 26, 2008	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K080839	ECHELON GRAY CARTRIDGE, MODEL ERC45M	May 21, 2008	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K080898	AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT	May 05, 2008	Substantially Equivalent	Tyco Healthcare Group LP
K073001	IDRIVES, IDRIVEC, IDRIVEF	Dec 18, 2007	Substantially Equivalent	Power Medical Interventions, Inc.
K073148	IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS	Dec 07, 2007	Substantially Equivalent	Power Medical Interventions, Inc.
K071920	AUTOSUTURE ABSORBABLE TACK AND APPLICATOR	Sep 28, 2007	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K071708	I45, I45S, I60, AND I60S	Sep 27, 2007	Substantially Equivalent	Power Medical Interventions, Inc.
K070887	ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)	May 25, 2007	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K071061	ABSORBATACK AND APPLICATOR	May 16, 2007	Substantially Equivalent	Sorbx, LLC
K062869	CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G	Feb 26, 2007	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K063746	POWER EXTENDERS MODEL# PEC200, PES200,PES200S	Jan 12, 2007	Substantially Equivalent	Power Medical Interventions, Inc.
K063075	NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS	Nov 02, 2006	Substantially Equivalent	Power Medical Interventions, Inc.
K062850	AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS	Oct 23, 2006	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K061649	POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH	Sep 01, 2006	Substantially Equivalent	Power Medical Interventions, Inc.
K061784	INSORB ABSORBABLE STAPLE, MODEL 1020	Jul 26, 2006	Substantially Equivalent	Incisive Surgical, Inc.
K061156	ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS	Jul 03, 2006	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K060494	EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM	Jul 03, 2006	Substantially Equivalent	Medchannel, LLC
K061095	AUTO SUTUR ENDO GIA STAPLERS	May 31, 2006	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K053631	CONTOUR TRANSTAR CURVED CUTTER STAPLER SET	Jan 30, 2006	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K052910	POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS	Nov 07, 2005	Substantially Equivalent	Power Medical Interventions, Inc.
K052415	POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS	Sep 29, 2005	Substantially Equivalent	Power Medical Interventions, Inc.
K051301	PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES	Aug 30, 2005	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K051848	SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079	Aug 11, 2005	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K050610	SALUTE FIXATION SYSTEM	May 25, 2005	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K051002	ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER	May 17, 2005	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K042492	HAND STC, MODEL 60MM	Oct 19, 2004	Substantially Equivalent	Niti Medical Technologies , Ltd.
K041159	JMS ABSORBABLE ANCHOR AND APPLICATOR	Jul 27, 2004	Substantially Equivalent	Jms, Inc.
K041331	BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER	Jun 15, 2004	Substantially Equivalent	Biopsy Sciences, LLC
K041201	ULTRACLIP II MR	Jun 03, 2004	Substantially Equivalent	Inrad
K040720	SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM	Jun 03, 2004	Substantially Equivalent	Power Medical Interventions, Inc.
K040109	HEMORRHAGE OCCLUDER PIN	Mar 25, 2004	Substantially Equivalent	Tools For Surgery, LLC
K040398	SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS	Mar 24, 2004	Substantially Equivalent	Power Medical Interventions, Inc.
K040038	CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G	Feb 04, 2004	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K040024	SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29	Feb 04, 2004	Substantially Equivalent	Power Medical Interventions, Inc.
K032973	REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS	Dec 18, 2003	Substantially Equivalent	Vanguard Medical Concepts, Inc.
K033602	INSORB ABSORBABLE STAPLE, MODEL SP-B20	Dec 16, 2003	Substantially Equivalent	Incisive Surgical, Inc.
K032696	AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT	Dec 01, 2003	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K032701	SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)	Sep 30, 2003	Substantially Equivalent	Power Medical Interventions, Inc.
K032347	BIOMARC TISSUE MARKER	Aug 21, 2003	Substantially Equivalent	Carbon Medical Technologies, Inc.
K030925	PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01	May 15, 2003	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K024117	INSORB ABSORBABLE STAPLES, MODEL SP-B20	Apr 22, 2003	Substantially Equivalent	Incisive Surgical, Inc.
K030653	SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS	Mar 31, 2003	Substantially Equivalent	Power Medical Interventions, Inc.
K030411	PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03	Mar 20, 2003	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K024275	AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER	Mar 14, 2003	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K023725	HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247	Feb 03, 2003	Substantially Equivalent	Marina Medical Instruments, Inc.
K022313	SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V	Dec 09, 2002	Substantially Equivalent	Power Medical Interventions, Inc.
K020804	AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER	Nov 19, 2002	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K021701	SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60	Jun 21, 2002	Substantially Equivalent	Power Medical Interventions, Inc.
K020779	PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS	Jun 05, 2002	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K021249	SURGASSIST FLEXSHAFT 2, MODEL FS2 14	May 15, 2002	Substantially Equivalent	Power Medical Interventions, Inc.
K020719	SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES	May 10, 2002	Substantially Equivalent	Power Medical Interventions, Inc.
K020343	SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL	Apr 10, 2002	Substantially Equivalent	Power Medical Interventions, Inc.
K014286	SALUTE, MODEL 3022	Mar 08, 2002	Substantially Equivalent	Onux Medical, Inc.
K013749	ENDOANCHOR AND OPENANCHOR	Feb 11, 2002	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K013860	AUTO SUTURE SURGICAL STAPLES	Dec 19, 2001	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K012809	SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45	Oct 26, 2001	Substantially Equivalent	Power Medical Interventions, Inc.
K012362	MODIFICATION TO VASCULAR CLOSURE DEVICE	Aug 23, 2001	Substantially Equivalent	Std Mfg., Inc.
K001807	TISSUE MARKER	May 03, 2001	Substantially Equivalent	Advanced Uroscience, Inc.
K003522	SALUTE	Feb 13, 2001	Substantially Equivalent	Onux Medical, Inc.
K003277	SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33	Dec 21, 2000	Substantially Equivalent	Powermed, Inc.
K003169	VASCULAR CLOSURE DEVICE	Dec 08, 2000	Substantially Equivalent	Std Mfg., Inc.
K001895	AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER	Dec 08, 2000	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K000060	GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007	Mar 27, 2000	Substantially Equivalent	Senorx, Inc.
K000608	SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM	Mar 07, 2000	Substantially Equivalent	Std Mfg., Inc.
K993785	ULTRACLIP TISSUE MARKER	Feb 04, 2000	Substantially Equivalent	Inrad
K991030	PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES	May 17, 1999	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K983318	FIXATION SYSTEM	Mar 01, 1999	Substantially Equivalent	General Surgical Innovations
K983400	AUTO SUTURE SITE MARKER CLIP	Feb 10, 1999	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K983536	PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS	Dec 18, 1998	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K980617	MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER	Apr 09, 1998	Substantially Equivalent	Urohealth Systems, Inc.
K970817	MICROMARK CLIP	Sep 11, 1997	Substantially Equivalent	Biopsys Medical, Inc.
K963015	SURGICAL STAPLE MARKER DEVICE (MODIFY)	Oct 07, 1996	Substantially Equivalent	Biopsys Medical, Inc.
K952239	AUTO SUTURE* MODIFIED LINEAR STAPLER**	Oct 03, 1995	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K950006	SURGICAL STAPLE MARKER	Mar 15, 1995	Substantially Equivalent	Biopsys Medical, Inc.
K942606	SURGICAL STAPLE	Aug 24, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K931103	STRYKER STAPLER SYSTEM	Oct 12, 1993	Substantially Equivalent	Stryker Endoscopy
K931056	DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING	Jul 08, 1993	Substantially Equivalent	American Cyanamid Co.
K922186	HEM-O-LOK -- MODIFICATION	Aug 06, 1992	Substantially Equivalent	Linvatec Corp.
K920752	ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER	Aug 06, 1992	Substantially Equivalent	ETHICON, Inc.
K921051	3M PRECISE BRAND INTERNAL SURGICAL STAPLES	Jul 16, 1992	Substantially Equivalent	3M Health Care, Ltd.
K915693	PROXIMATE ABSORBABLE STAPLES	Mar 19, 1992	Substantially Equivalent	ETHICON, Inc.
K915489	AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE	Jan 31, 1992	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K914130	AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES	Oct 17, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K913832	AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER	Oct 17, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K913802	AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER	Oct 17, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K913211	AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER	Sep 25, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K913411	DAVIS & GECK VALTRAC(R) BIOFRAG ANASTOMOSIS RING	Sep 06, 1991	Substantially Equivalent	Davis & Geck, Inc.
K913139	IMPLANTABLE METAL STAPLES	Sep 06, 1991	Substantially Equivalent	ETHICON, Inc.
K911252	PRECISE BARND PI DISPOSABLE SURGICAL STAPLES	Jul 25, 1991	Substantially Equivalent	3M Medical Products Group
K910897	PRECISE FLEXISTAPLER CIRCULAR STAPLER, SERIES 398X	Apr 01, 1991	Substantially Equivalent	3M Medical Products Group
K910192	AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER	Feb 11, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K905106	AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER	Jan 31, 1991	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K900129	MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*	Feb 27, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K900055	MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS	Feb 09, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K900043	MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER	Feb 09, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K892233	AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER	Apr 28, 1989	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K890841	TITANIUM STAPLES	Apr 19, 1989	Substantially Equivalent	ETHICON, Inc.
K890270	AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER*	Mar 17, 1989	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K890447	HEMORRHAGE OCCLUDOR	Feb 23, 1989	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K885222	PRECISE ILA AND ILAN SURGICAL STAPLES	Feb 03, 1989	Substantially Equivalent	3M Company
K881484	BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING	May 04, 1988	Substantially Equivalent	Davis & Geck, Inc.
K873748	RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT	Jan 06, 1988	Substantially Equivalent	Deknatel, Inc.
K864146	DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)	Nov 05, 1986	Substantially Equivalent	Cardio Thoracic Systems
K855047	AUTO SUTURE TITANIUM SURGICAL STAPLES	Jan 14, 1986	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K851122	PI-PNEUMO INTESTINAL STAPLING CARTRIDGE	Apr 25, 1985	Substantially Equivalent	Surgeons Choice, Inc.
K843399	SURGEONS CHOICE PI VASCULAR STAPLING	Nov 05, 1984	Substantially Equivalent	Surgeons Choice, Inc.
K843603	AUTO SUTURE POLY GIA SURGICAL STAPLER	Oct 31, 1984	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K843034	DISPOSABLE LINEAR CUTTER	Sep 17, 1984	Substantially Equivalent	ETHICON, Inc.
K833698	AMER. V. MUELLER SURG. STAPLES ILA	Jan 25, 1984	Substantially Equivalent	American Heyer Schulte
K833704	AMER. V. MUELLER SURGICALSTAPLES-CARTR	Dec 29, 1983	Substantially Equivalent	American Heyer Schulte
K823552	APPOSE SKIN STAPLER & REMOVER	Jun 15, 1983	Substantially Equivalent	American Cyanamid Co.
K830199	AUTO SUTURE TA DISPOS-STAPLE CART	Apr 12, 1983	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K822345	DISPOSABLE LINEAR STAPLER (LSF)	Sep 21, 1982	Substantially Equivalent	ETHICON, Inc.
K821994	DISPOSABLE LINEAR STAPLER-(LSR)	Aug 03, 1982	Substantially Equivalent	ETHICON, Inc.
K810324	AUTOMATIC HEMOCLIP APPLIER, 527700	Mar 20, 1981	Substantially Equivalent	Edward Weck, Inc.
K801154	PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.	Jun 20, 1980	Substantially Equivalent	ETHICON, Inc.
K780695	AUTO SUTURE DISPOSABLE STAPLING INSTRU.	Jun 22, 1978	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K780586	MICROCLIP, WILLIAMS	May 16, 1978	Substantially Equivalent	Richard'S Medical Equip., Inc.
K771178	DISP. LOADING UNIT, AUTO, SUTURE	Oct 18, 1977	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K761064	COVENTRY STAPLE	Dec 30, 1976	Substantially Equivalent	Depuy, Inc.