510(k) Report

Devices descending from K973170

237 later devices reach Sis Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+6K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+6K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+6K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+6K182725ApisSweetbio, Inc.20192—
+6K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+6K180776Cytal Wound ParticulateAcell, Inc.20180—
+6K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+6K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+6K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+6K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+6K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+6K151083BioBridge Collagen MatrixFibralign Corporation20169—
+6K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+6K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+6K140501Xenmatrix Surgical GraftC. R. Bard20140—
+6K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+6K123128Seri Surgical ScaffoldAllergan20135—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+6K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+7K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+7K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+7K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K211972Omeza Collagen MatrixOmeza, LLC20210—
+7K172545SERI ContourSofregen Medical, Inc.20170—
+7K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+7K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+7K140533Galaflex MeshTepha, Inc.20143—
+8K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+8K202425SurgiLattice scaffoldTepha, Inc.20210—
+8K162922GalaFORM 3DTepha, Inc.20170—
+8K161092GalaSHAPE 3DTepha, Inc.201611