510(k) Report

Devices descending from K043056

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+1K130997NeoveilGunze Limited20133—
+1K131658Gore Seamguard ReinforcementW. L. Gore & Associates, Inc.20131—
+1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+1K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+1K053200Gore Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200511
+1K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates20050—
+2K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.20230—
+2K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+2K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+2K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+2K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+2K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.20150—
+2K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+2K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+2K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+2K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+2K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+2K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+2K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+2K070644Gore Seamguard Staple Line Reinforcement Material for Circular StaplersW. L. Gore & Associates, Inc.20070—
+3K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+3K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+3K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+3K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+3K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+3K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+3K191070Signia Small Diameter ReloadsCovidien201927
+3K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+3K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+3K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+3K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+3K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+3K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+3K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+3K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+3K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+3K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+3K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+3K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+3K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+3K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+3K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+3K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+3K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+3K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+3K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+3K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+4K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+4K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+4K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+4K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+4K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+4K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+4K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+4K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+4K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+4K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+4K160176Signia StaplerCovidien2016514
+4K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+4K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+4K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+4K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+4K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+5K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+5K202864Tri-Staple 2.0 ReloadsCovidien20201—
+5K201672Signia Stapler (with new software)Covidien20200—
+5K180010AtriClip FLEX-VAtriCure, Inc.20188—
+5K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+6K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+7K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+8K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+9K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+9K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+9K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+10K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+10K232295LAA Exclusion SystemSyntheon, LLC20231—