510(k) Report

Devices descending from K013346

144 later devices reach Gore Drapeable ST/LT Regenerative Membrane through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+6K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+6K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+6K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+6K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+6K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+6K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+6K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+6K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+6K160176Signia StaplerCovidien2016514
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+6K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+6K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+6K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+6K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+6K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K242187BioBrace®Conmed Corporation20241—
+7K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+7K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+7K202864Tri-Staple 2.0 ReloadsCovidien20201—
+7K201672Signia Stapler (with new software)Covidien20200—
+7K180010AtriClip FLEX-VAtriCure, Inc.20188—
+7K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+7K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+8K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+9K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+9K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+10K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+10K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+11K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+11K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+11K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+12K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+12K232295LAA Exclusion SystemSyntheon, LLC20231—