510(k) Report

Devices descending from K993948

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+5K083898SurgimendTei Biosciences, Inc.200993
+5K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864
+5K081327RelimeshHerniamesh S.R.L.20080—
+5K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+6K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+6K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+6K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+6K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+6K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+6K211972Omeza Collagen MatrixOmeza, LLC20210—
+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—
+7K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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