510(k) Report

Devices descending from K921895

410 later devices reach Tissue Patch, Tissue Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+5K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+5K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+5K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+5K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+5K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+5K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+5K162554Gentrix Surgical MatrixAcell, Inc.20162—
+5K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+5K160400Miromatrix Biological MeshMiromatrix Medical, Inc.20160—
+5K153754MicroMatrixAcell, Inc.20160—
+5K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+5K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+5K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+5K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+5K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+5K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K140533Galaflex MeshTepha, Inc.20143—
+5K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+5K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+5K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+5K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+5K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+5K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+5K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112409Matristem Wound MatrixAcell, Inc.20117—
+5K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+5K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+5K103787Medeor MatrixKensey Nash Corp.20112—
+5K100984Xylos Vessel GuardXylos Corporation20100—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+5K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+5K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+5K083898SurgimendTei Biosciences, Inc.200993
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+5K082103LTM Wound DressingLifecell Corp.20087—
+5K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+5K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+5K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+5K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+5K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+6K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+6K242187BioBrace®Conmed Corporation20241—
+6K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+6K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+6K233533NerveTapeBiocircuit Technologies, Inc.20240—
+6K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+6K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+6K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+6K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+6K211132ARISTE AB MeshAriste Medical, LLC20220—
+6K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+6K202425SurgiLattice scaffoldTepha, Inc.20210—
+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—
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+6K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+6K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+6K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—