510(k) Report

Devices descending from K961810

409 later devices reach Supple Peri-Guard Pericardium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+1K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc.1998313
+1K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19983362
+1K980431SurgisisCook Biotech, Inc.1998284—
+1K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc.19971—
+2K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.202304
+2K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.202201
+2K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.202201
+2K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+2K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+2K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+2K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.20151—
+2K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc.20141Class I
+2K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K134033Miromatrix Biological MeshMiromatrix Medical, Inc.20142—
+2K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+2K111695Hybrid GraftCook Biotech, Inc.20120—
+2K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+2K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090688Cook Urological GraftCook Biotech, Inc.20090—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+2K053622Surgisis Ocular GraftIop, Inc.20062—
+2K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+2K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+2K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+2K050337Sis Fistula PlugCook Biotech, Inc.200527—
+2K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+2K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc.200417—
+2K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc.20041—
+2K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+2K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Synovis Surgical Innovations2004241
+2K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations200469—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+2K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+2K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc.20031—
+2K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+2K023237Xylos Surgical MeshXylos Corporation200312—
+2K021056PermacolTissue Science Laboratories, Plc200251—
+2K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+2K021105Fortaflex Surgical MeshOrganogenesis, Inc.200242—
+2K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+2K991296TutopatchTutogen Medical U.S., Inc.20000—
+2K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc.2000147—
+2K992159Surgisis SlingCook Biotech, Inc.1999204—
+2K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc.19980—
+2K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892—
+3K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+3K202430Kerecis ReconstructKerecis Limited20213—
+3K190882XenoSure Biologic PatchLemaitre Vascular20200—
+3K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+3K182493Bovine Pericardial Tissue PatchTisgenx20190—
+3K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+3K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+3K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+3K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+3K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+3K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)2016121
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K150341Miromatrix Biological Mesh RSMiromatrix Medical, Inc.20151—
+3K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc.20142—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+3K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+3K132660Nerve CuffCook Biotech Incorporated20146—
+3K130997NeoveilGunze Limited20133—
+3K131015Biodesign Onlay Dural Graft or Biodesign Duraplasty GraftCook Biotech, Inc.20130—
+3K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+3K101961Tigerpaw SystemLaax, Inc.20102—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc.20091—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+3K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+3K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K081882Modification to Xylos Surgical MeshXylos Corporation200811—
+3K080898Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line…Tyco Healthcare Group LP20084824
+3K071986LTM-RC Surgical MeshLifecell Corp.20073—
+3K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc.20072—
+3K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+3K070560LRTM Surgical MeshLifecell Corp.2007502
+3K063556Peripatch Endo-SleevePm Devices, Inc.20070—
+3K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012