510(k) Report

Devices descending from K960653

193 later devices reach Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+7K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+7K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+7K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+7K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+7K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+7K160176Signia StaplerCovidien2016514
+7K151083BioBridge Collagen MatrixFibralign Corporation20169—
+7K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+7K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+7K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+7K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+7K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+7K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+7K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+7K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+8K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+8K232847SiOxD Wound MatrixSioxmed, LLC20231—
+8K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+8K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+8K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+8K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+8K202864Tri-Staple 2.0 ReloadsCovidien20201—
+8K201672Signia Stapler (with new software)Covidien20200—
+8K180010AtriClip FLEX-VAtriCure, Inc.20188—
+8K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+8K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+8K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+8K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+9K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+9K260317Artelon Convenience KitsInternational Life Sciences20260—
+9K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+9K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+9K242187BioBrace®Conmed Corporation20241—
+9K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+9K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+10K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+10K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+10K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+10K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+11K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+11K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—
+12K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+12K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+12K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+13K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+13K232295LAA Exclusion SystemSyntheon, LLC20231—