510(k) Report

Devices descending from K955364

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145—
+2K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+2K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+3K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+4K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+4K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K130997NeoveilGunze Limited20133—
+4K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K0709184DDOMECousin Biotech20070—
+4K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+4K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+4K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+4K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations200469—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC20221—
+5K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+5K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+5K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+5K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+5K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+5K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+5K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+5K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+5K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+5K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+5K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+6K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+6K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC20260—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+6K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+6K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+6K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+6K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+6K191070Signia Small Diameter ReloadsCovidien201927
+6K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+6K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+6K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+6K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+6K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+6K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+6K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+6K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+6K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+6K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+6K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+6K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+6K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+6K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+6K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+6K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+6K141721Bovine Pericardium PatchCollafirm, LLC20140—
+6K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+6K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+6K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+6K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+6K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+6K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+6K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+6K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+6K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+6K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+6K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+7K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+7K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+7K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+7K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+7K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+7K222189SiOxD Wound MatrixSioxmed, LLC20222—
+7K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+7K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+7K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+7K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+7K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+7K193583Restrata®Acera Surgical, Inc.202011