510(k) Report

Devices descending from K980431

284 later devices reach Surgisis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+1K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+1K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+1K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+1K134033Miromatrix Biological MeshMiromatrix Medical, Inc.20142—
+1K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+1K111695Hybrid GraftCook Biotech, Inc.20120—
+1K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+1K090688Cook Urological GraftCook Biotech, Inc.20090—
+1K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+1K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+1K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+1K053622Surgisis Ocular GraftIop, Inc.20062—
+1K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+1K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+1K050337Sis Fistula PlugCook Biotech, Inc.200527—
+1K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+1K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+1K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+1K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+1K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+1K021056PermacolTissue Science Laboratories, Plc200251—
+1K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+1K021105Fortaflex Surgical MeshOrganogenesis, Inc.200242—
+1K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+1K992159Surgisis SlingCook Biotech, Inc.1999204—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892—
+2K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+2K202430Kerecis ReconstructKerecis Limited20213—
+2K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+2K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+2K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+2K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+2K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+2K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+2K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+2K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+2K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+2K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+2K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+2K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+2K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+2K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+2K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.20151—
+2K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+2K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+2K132660Nerve CuffCook Biotech Incorporated20146—
+2K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+2K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K120605Permacol Surgical ImplantCovidien, LLC20124—
+2K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+2K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+2K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+2K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+2K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+2K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+2K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+2K071986LTM-RC Surgical MeshLifecell Corp.20073—
+2K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+2K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+2K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+2K070560LRTM Surgical MeshLifecell Corp.2007502
+2K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+2K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+2K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+2K060829CosmatrixTei Biosciences, Inc.200618—
+2K052830SportmeshArtimplant AB200644—
+2K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K051190Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20051—
+2K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+2K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+2K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+2K031188OrthomendTei Biosciences, Inc.200336—
+2K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+2K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+2K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+2K020654Stratasis Sling KitCook Biotech, Inc.20020—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+3K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+3K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+3K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+3K243843Tendon Protect (50242)Kerecis Limited20250—
+3K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+3K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+3K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+3K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+3K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+3K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+3K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+3K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+3K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821