510(k) Report

Devices descending from K830889

307 later devices reach Dexon 'S' Polyglycolic Acid Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+3K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.200238—
+3K021107Fortaflex Surgical SlingOrganogenesis, Inc.20020—
+3K020654Stratasis Sling KitCook Biotech, Inc.20020—
+3K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+4K261543Phasix ST Parastomal Hernia MeshDavol, Inc., A Subsidiary of C.R. Bard, Inc.20260—
+4K251844Kerecis SurgiBind (50241)Kerecis Limited20250—
+4K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.20250—
+4K243843Tendon Protect (50242)Kerecis Limited20250—
+4K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd.20250—
+4K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+4K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+4K223074CorNeat EverPatchCorneat Vision, Ltd.202303
+4K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+4K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+4K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+4K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.)20191—
+4K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+4K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K173143Phasix ST MeshC.R. Bard, Inc.20181—
+4K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+4K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+4K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated20171—
+4K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+4K162554Gentrix Surgical MatrixAcell, Inc.20162—
+4K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)20161—
+4K160400Miromatrix Biological MeshMiromatrix Medical, Inc.20160—
+4K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc20160—
+4K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+4K150668Biodesign Enterocutaneous Fistula PlugCook Biotech Incorprated20150—
+4K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc.20152—
+4K150712LTM-Perforated Surgical MeshLifecell Corporation20150—
+4K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+4K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+4K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+4K123128Seri Surgical ScaffoldAllergan20135—
+4K123356Fortiva Porcine DermisRti Biologics, Inc.20131—
+4K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+4K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc.2012415
+4K121289LTM-Labaroscopic Surgical MeshLifecell Corp.20121—
+4K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+4K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+4K103787Medeor MatrixKensey Nash Corp.20112—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K093799Tornier Surgical MeshTornier, Inc.20102—
+4K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+4K092926Acell Matristem Wound SheetAcell, Inc.200914—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K090778Mta Protective SheetXylos Corporation20092—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083898SurgimendTei Biosciences, Inc.200993
+4K082176LTM-BPS Surgical MeshLifecell Corp.200814—
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+4K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+4K080353LTM-T Surgical MeshLifecell Corp.20084—
+4K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+4K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+4K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—
+4K0709184DDOMECousin Biotech20070—
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K061474Collawound DressingCollamatrix Co., Inc.20063—
+4K060888Acell Powder Wound DressingAcell, Inc.20065—
+4K060984Xenform Soft Tissue Repair MatrixTei Biosciences, Inc.20060—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.200517—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+5K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+5K233533NerveTapeBiocircuit Technologies, Inc.20240—
+5K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+5K211132ARISTE AB MeshAriste Medical, LLC20220—
+5K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter20210—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K201000Biodesign Staple Line ReinforcementCook Biotech Incorporated20200—
+5K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd.20180—
+5K172593XCelliStem Wound PowderStemsys20181—
+5K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+5K172545SERI ContourSofregen Medical, Inc.20170—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—