510(k) Report

Devices descending from K923657

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+1K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892—
+1K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc.19971—
+1K963967Glycar Pericardial PatchGlycar, Inc.199720Class I
+1K970561Graft PatchOrganogenesis, Inc.1997285—
+1K963175Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingGlycar, Inc.19960—
+1K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996409—
+1K961811Peri-Guard PericardiumBio-Vascular, Inc.1996339—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+2K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+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—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+2K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003143—
+2K023328Reinforced Absorbable Synthetic Surgical MeshCenter For Biomaterials and Advanced Technologies20020—
+2K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+2K021105Fortaflex Surgical MeshOrganogenesis, Inc.200242—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+2K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc.1998313
+2K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc.19980—
+2K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19983362
+2K980431SurgisisCook Biotech, Inc.1998284—
+3K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.202304
+3K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.202201
+3K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.202201
+3K190882XenoSure Biologic PatchLemaitre Vascular20200—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K182493Bovine Pericardial Tissue PatchTisgenx20190—
+3K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.20151—
+3K142461VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc.20141Class I
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+3K134033Miromatrix Biological MeshMiromatrix Medical, Inc.20142—
+3K130872CardiocelCelxcel Pty, Ltd.20143—
+3K130547Endoform Reconstructive TemplateMesynthe, Ltd.20135—
+3K111695Hybrid GraftCook Biotech, Inc.20120—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+3K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc.20110—
+3K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+3K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+3K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+3K090688Cook Urological GraftCook Biotech, Inc.20090—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+3K071555Fortagen Oral MembraneOrganogenesis, Inc.20071—
+3K063556Peripatch Endo-SleevePm Devices, Inc.20070—
+3K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+3K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+3K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+3K053622Surgisis Ocular GraftIop, Inc.20062—
+3K052830SportmeshArtimplant AB200644—
+3K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+3K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+3K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+3K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+3K050246Sis Dermal Augmentation StrandCook Biotech, Inc.20054—
+3K050337Sis Fistula PlugCook Biotech, Inc.200527—
+3K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.200477—
+3K043366Permacol Surgical ImplantTissue Science Laboratories, Plc200474—
+3K042809CuffpatchOrganogenesis, Inc.200472—
+3K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+3K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Synovis Surgical Innovations2004241
+3K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations200469—
+3K034039Sis Plastic Surgery MatrixCook Biotech, Inc.200493—
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc.2003102—
+3K031850Durasis Dural SubstituteCook Biotech, Inc.20032—
+3K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc.20031—
+3K031188OrthomendTei Biosciences, Inc.200336—
+3K031069Surgisis Nerve CuffCook Biotech, Inc.200310—
+3K023237Xylos Surgical MeshXylos Corporation200312—
+3K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+3K021056PermacolTissue Science Laboratories, Plc200251—
+3K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+3K020455Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.200256—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+3K991296TutopatchTutogen Medical U.S., Inc.20000—
+3K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc.2000147—
+3K992159Surgisis SlingCook Biotech, Inc.1999204—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+4K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+4K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC20192—
+4K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.20181—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+4K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—