510(k) Report

Devices descending from K961811

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+1K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Bio-Vascular, Inc.19983362
+1K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc.19971—
+2K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.202304
+2K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.20151—
+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—
+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—
+2K023237Xylos Surgical MeshXylos Corporation200312—
+2K022044Surgisis Staple Line ReinforcementCook Biotech, Inc.20026—
+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—
+2K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc.19980—
+3K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.202201
+3K190882XenoSure Biologic PatchLemaitre Vascular20200—
+3K182493Bovine Pericardial Tissue PatchTisgenx20190—
+3K162934Biodesign Parastomal Hernia Repair GraftCook Biotech Incorporated20171—
+3K133011Diaphragmatic Hernia GraftCook Biotech, Inc.201411
+3K130997NeoveilGunze Limited20133—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+3K101961Tigerpaw SystemLaax, Inc.20102—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+3K080442Seriscaffold Surgical MeshSerica Technologies, Inc.2008141
+3K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+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
+3K063556Peripatch Endo-SleevePm Devices, Inc.20070—
+3K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+3K062915Veritas Collagen MatrixSynovis Surgical Innovations2006151
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K052830SportmeshArtimplant AB200644—
+3K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc.20053—
+3K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+3K050355Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models…Tissue Science Laboratories, Plc200554—
+3K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations200448
+3K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+3K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+3K031188OrthomendTei Biosciences, Inc.200336—
+3K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+3K021056PermacolTissue Science Laboratories, Plc200251—
+3K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center2002145—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+4K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+4K221487NEOVEIL Staple Line ReinforcementGunze Limited20220—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+4K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20161—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+4K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading UnitsB.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20152—
+4K141721Bovine Pericardium PatchCollafirm, LLC20140—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+4K130872CardiocelCelxcel Pty, Ltd.20143—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+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
+4K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+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—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations20082—
+4K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+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—
+4K0709184DDOMECousin Biotech20070—
+4K070560LRTM Surgical MeshLifecell Corp.2007502
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—