510(k) Report

Devices descending from K982597

253 later devices reach Fibrcol Plus Collagen Wound Dressing with Alginate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112580Collagen Wound DressingDalim Tissen Co., Ltd.20124—
+4K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+4K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+4K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+4K110318ExcellagenTissue Repair Company20110—
+4K112399Unite BiomatrixSynovis Orthopedic & Woundcare20110—
+4K112409Matristem Wound MatrixAcell, Inc.20117—
+4K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+4K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+4K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+4K092257JaloskinFidia Advanced Biopolymers Srl20100—
+4K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+4K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+4K090288Orthadapt PRPegasus Biologics, Inc.20097—
+4K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+4K083307Synthasome X-RepairSynthasome, Inc.20099—
+4K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+4K082103LTM Wound DressingLifecell Corp.20087—
+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—
+4K071065Orthadapt BioimplantPegasus Biologics, Inc.200744—
+4K053562Zimmer Collagen Repair PatchTissue Science Laboratories, Plc200641—
+4K043259Bioblanket Surgical MeshKensey Nash Corp.200510—
+4K051766OrthomendTei Biosciences, Inc.200535—
+4K042809CuffpatchOrganogenesis, Inc.200472—
+4K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+5K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+5K253204CatalyzeBioTissue Holdings, Inc.20260—
+5K261224MatriDermMedskin Solutions Dr. Suwelack AG20260—
+5K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+5K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+5K252673LacertaMatrixLacerta Life Science20251—
+5K253339TheracorStimlabs, LLC20250—
+5K250864MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG20250—
+5K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+5K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+5K242302RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc.20240—
+5K241080Kerecis Parvus (50207)Kerecis Limited20241—
+5K2326023DMatrix Surgical MeshPrintbio, Inc.20241—
+5K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+5K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+5K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+5K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.20220—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+5K213231Kerecis SiliconeKerecis Limited20221—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K203267The BioBrace ImplantBiorez, Inc.20214—
+5K193583Restrata®Acera Surgical, Inc.202011
+5K192386KeraStat CreamKeranetics20200—
+5K192112FlexBand PlusInternational Life Sciences20199—
+5K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+5K182725ApisSweetbio, Inc.20192—
+5K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+5K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+5K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+5K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+5K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+5K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+5K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+5K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+5K162554Gentrix Surgical MatrixAcell, Inc.20162—
+5K152721Cytal Wound MatrixAcell, Inc.201565
+5K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+5K141394X-RepairSynthasome20140—
+5K141499X-RepairslSynthasome, Inc.20140—
+5K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+5K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+5K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+5K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+5K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+5K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+5K103787Medeor MatrixKensey Nash Corp.20112—
+5K093799Tornier Surgical MeshTornier, Inc.20102—
+5K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+5K090778Mta Protective SheetXylos Corporation20092—
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+5K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+5K080353LTM-T Surgical MeshLifecell Corp.20084—
+5K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+5K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+5K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+5K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+6K260218LacertaMatrixLacerta Life Sciences20260—
+6K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+6K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+6K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+6K242187BioBrace®Conmed Corporation20241—
+6K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+6K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—