510(k) Report

Devices descending from K032865

102 later devices reach Gore Seamguard Bioabsorbable Staple Line Reinforcement Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+1K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+1K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+1K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations200469—
+2K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC20221—
+2K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+2K130997NeoveilGunze Limited20133—
+2K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+2K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+2K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+2K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+2K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+2K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+2K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+3K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC20260—
+3K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+3K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+3K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+3K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+3K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+3K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+3K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+3K141721Bovine Pericardium PatchCollafirm, LLC20140—
+3K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+3K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+3K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+3K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+3K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+3K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+3K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+3K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+3K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+3K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+4K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+4K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+4K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+4K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+4K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+4K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+4K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K191070Signia Small Diameter ReloadsCovidien201927
+4K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+4K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+4K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+4K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+4K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+4K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+4K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+4K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+4K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+4K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+4K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+4K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+4K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+4K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+4K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+4K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+5K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+5K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+5K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+5K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+5K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+5K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+5K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+5K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+5K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+5K160176Signia StaplerCovidien2016514
+5K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+5K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+5K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+5K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+5K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+5K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+6K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+6K202864Tri-Staple 2.0 ReloadsCovidien20201—
+6K201672Signia Stapler (with new software)Covidien20200—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K180010AtriClip FLEX-VAtriCure, Inc.20188—
+6K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+8K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+9K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+10K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+10K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+10K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—