510(k) Report

Devices descending from K914575

335 later devices reach Sorbsan Topical Wound Dressing (Modified) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K081327RelimeshHerniamesh S.R.L.20080—
+7K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K260317Artelon Convenience KitsInternational Life Sciences20260—
+8K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+8K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K250395BioBrace ® RC Delivery SystemConmed Corporation20250—
+8K222220SpinMedix Absorbable Fibrous MembraneCelestray Biotech Company, LLC.,20230—
+8K181641QuikClot RadialZ-Medica, LLC20180—
+8K171357SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences)201702
+8K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+8K162965SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionTei Biosciences, Inc.201701
+8K151083BioBridge Collagen MatrixFibralign Corporation20169—
+8K142887SIS Inguinal Hernia Repair GraftCook Biotech Incorprated20150—
+8K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc.20142—
+8K140501Xenmatrix Surgical GraftC. R. Bard20140—
+8K131143Trellis Collagen RibbonWrightmedicaltechnologyinc201310—
+8K123128Seri Surgical ScaffoldAllergan20135—
+8K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+8K112567Biomerix AssureBiomerix Corporation20110—
+8K111436Porcine Surgical Mesh, Porcine Dermal MatrixBrennen Medical, LLC20111—
+8K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+9K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+9K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+9K172545SERI ContourSofregen Medical, Inc.20170—
+9K162193XenMatrix AB Surgical GraftC. R. Bard20160—
+9K151177XenMatrix AB Surgical GraftC. R. Bard20151—
+9K140533Galaflex MeshTepha, Inc.20143—
+10K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+10K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+10K202425SurgiLattice scaffoldTepha, Inc.20210—
+10K162922GalaFORM 3DTepha, Inc.20170—
+10K161092GalaSHAPE 3DTepha, Inc.201611