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
+6K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+6K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+6K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+6K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+6K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+6K211132ARISTE AB MeshAriste Medical, LLC20220—
+6K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+6K211972Omeza Collagen MatrixOmeza, LLC20210—
+6K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+6K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+6K180776Cytal Wound ParticulateAcell, Inc.20180—
+6K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+6K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+6K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+6K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+6K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+6K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+6K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+6K100984Xylos Vessel GuardXylos Corporation20100—
+6K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+6K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+6K083898SurgimendTei Biosciences, Inc.200993
+6K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+6K081327RelimeshHerniamesh S.R.L.20080—
+6K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+7K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+7K260317Artelon Convenience KitsInternational Life Sciences20260—
+7K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+7K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+7K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+7K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+7K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+7K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+7K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+7K151083BioBridge Collagen MatrixFibralign Corporation20169—
+7K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+7K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+7K140501Xenmatrix Surgical GraftC. R. Bard20140—
+7K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+7K123128Seri Surgical ScaffoldAllergan20135—
+7K112567Biomerix AssureBiomerix Corporation20110—
+7K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+7K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+8K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+8K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+8K172545SERI ContourSofregen Medical, Inc.20170—
+8K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+8K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+8K140533Galaflex MeshTepha, Inc.20143—
+9K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+9K202425SurgiLattice scaffoldTepha, Inc.20210—
+9K162922GalaFORM 3DTepha, Inc.20170—
+9K161092GalaSHAPE 3DTepha, Inc.201611