510(k) Report

Devices descending from K040119

69 later devices reach Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+1K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+1K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+2K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+2K141721Bovine Pericardium PatchCollafirm, LLC20140—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+2K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+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—
+2K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+2K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+2K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+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—
+3K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+3K191070Signia Small Diameter ReloadsCovidien201927
+3K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+3K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+3K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+3K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+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—
+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—
+3K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+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—
+4K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+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—
+4K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+4K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+4K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+4K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+4K160176Signia StaplerCovidien2016514
+4K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+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—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—