510(k) Report

Devices descending from K921895

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+4K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+4K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+4K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+4K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+4K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+4K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.20151—
+4K141721Bovine Pericardium PatchCollafirm, LLC20140—
+4K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+4K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K132660Nerve CuffCook Biotech Incorporated20146—
+4K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K111064Tigerpaw System IILaax, Inc.20111Class I
+4K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+4K092926Acell Matristem Wound SheetAcell, Inc.200914—
+4K090880Xylos Porous Surgical MeshXylos Corporation20090—
+4K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+4K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+4K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.20088—
+4K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+4K071986LTM-RC Surgical MeshLifecell Corp.20073—
+4K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+4K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+4K0709184DDOMECousin Biotech20070—
+4K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+4K070560LRTM Surgical MeshLifecell Corp.2007502
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K060829CosmatrixTei Biosciences, Inc.200618—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+4K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+4K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+4K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+4K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+4K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+4K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+4K020654Stratasis Sling KitCook Biotech, Inc.20020—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+5K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+5K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+5K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler…Beijing Biosis Healing Biolog Ical Technology Co., Ltd.20210—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+5K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp.20190—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191070Signia Small Diameter ReloadsCovidien201927
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—