510(k) Report

Devices descending from K954665

205 later devices reach Glycar Staple Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992159Surgisis SlingCook Biotech, Inc.1999204—
+2K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated20166—
+2K130006Biodesign Surgisis Anterior Posterior Pelvic Floor GraftsCook Biotech Incorporated20130—
+2K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+2K090688Cook Urological GraftCook Biotech, Inc.20090—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K062320Surgisis Peyronie's Repair Graft, Model SPR-100Cook Biotech, Inc.20061—
+2K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.2005301
+2K050337Sis Fistula PlugCook Biotech, Inc.200527—
+2K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+2K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+2K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+2K020654Stratasis Sling KitCook Biotech, Inc.20020—
+2K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+3K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated20194—
+3K170016Biodesign Fistula PlugCook Biotech Incorporated20175—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+3K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited)20160—
+3K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated201601
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+3K103787Medeor MatrixKensey Nash Corp.20112—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K082682Surgisis Biodesign Enterocutaneous Fistula PlugCook Biotech, Inc.20091—
+3K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+3K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+3K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+3K062729Surgisis RVP Recto-Vaginal Fistula PlugCook Biotech, Inc.2006012
+3K052830SportmeshArtimplant AB200644—
+3K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+3K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+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—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+4K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K202430Kerecis ReconstructKerecis Limited20213—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K140501Xenmatrix Surgical GraftC. R. Bard20140—
+4K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+4K092926Acell Matristem Wound SheetAcell, Inc.200914—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K082677Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc.200811
+4K082387Apogee and Perigee Systems with Intepro Lite and Intexen LP, Part of the Ams; Pelvic…American Medical Systems20080—
+4K081710Apogee and Perigee Systems with PC Coated Intepro LiteAmerican Medical Systems20080—
+4K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc.200811—
+4K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+4K071986LTM-RC Surgical MeshLifecell Corp.20073—
+4K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K0709184DDOMECousin Biotech20070—
+4K070993Topas SystemAmerican Medical Systems, Inc.20071—
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+4K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+5K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+5K243843Tendon Protect (50242)Kerecis Limited20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702