510(k) Report

Devices descending from K914575

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202830Axiostat PatchAdvamedica, Inc.20210—
+6K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+6K193583Restrata®Acera Surgical, Inc.202011
+6K192386KeraStat CreamKeranetics20200—
+6K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+6K191536Biatain Silicone AgColoplast A/S20200—
+6K192112FlexBand PlusInternational Life Sciences20199—
+6K182811gel-e Flex+Gel-E, Inc.20191—
+6K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20190—
+6K182725ApisSweetbio, Inc.20192—
+6K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc.20180—
+6K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+6K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd20180—
+6K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.20181—
+6K171817Biodesign Diaphragmatic Hernia GraftCook Biotech Incorporated20180—
+6K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+6K172937Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC20170—
+6K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.20170—
+6K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+6K162388CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF)Curaseal, Inc.20170—
+6K162554Gentrix Surgical MatrixAcell, Inc.20162—
+6K152721Cytal Wound MatrixAcell, Inc.201565
+6K150985Medihoney Wound GelDerma Sciences, Inc.201501
+6K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+6K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+6K143124KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.20152—
+6K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+6K141394X-RepairSynthasome20140—
+6K141499X-RepairslSynthasome, Inc.20140—
+6K132025Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical20136—
+6K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+6K112864Softseal-CChitogen, Inc.20120—
+6K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+6K111337Tornier Collagen Coated Biofiber ScaffoldTornier, Inc.20120—
+6K110581Propatch Soft Tissue Repair MatrixCryolife, Inc.20120—
+6K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+6K111584Xylos Macro-Porous Surgical MeshXylos Corporation20115—
+6K103787Medeor MatrixKensey Nash Corp.20112—
+6K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+6K100693Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial DressingMedtrade Products Limited20101—
+6K093799Tornier Surgical MeshTornier, Inc.20102—
+6K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc.20105—
+6K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+6K090778Mta Protective SheetXylos Corporation20092—
+6K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+6K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+6K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+6K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc.200812—
+6K080353LTM-T Surgical MeshLifecell Corp.20084—
+6K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.2007174
+6K070625Pelvimesh / Hermesh 7Marketing Solutions, Inc.20071—
+6K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+6K060989Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc.2006131
+6K061030Bioblanket Surgical MeshKensey Nash Corporation20064—
+7K260218LacertaMatrixLacerta Life Sciences20260—
+7K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+7K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.20250—
+7K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+7K242187BioBrace®Conmed Corporation20241—
+7K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+7K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+7K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+7K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222143Apis (R), Veris (TM)Sweetbio, Inc.20230—
+7K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+7K230316FlexBand; FlexPatch; FlexBand PlusInternational Life Sciences202333
+7K220673Sterile Silver Alginate Wound DressingQingdao Bright Moon Biomedical Materials Co., Ltd.20230—
+7K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+7K211132ARISTE AB MeshAriste Medical, LLC20220—
+7K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+7K211972Omeza Collagen MatrixOmeza, LLC20210—
+7K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+7K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+7K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+7K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+7K180776Cytal Wound ParticulateAcell, Inc.20180—
+7K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+7K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.)20170—
+7K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+7K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+7K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—
+7K121817Vcare aIVT Medical, Ltd.20130—
+7K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+7K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc.20123—
+7K120019Collagen RibbonWrightmedicaltechnologyinc201211—
+7K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+7K100313Hydrofix Surgical SheetMimedx Group, Inc.20110—
+7K102788Tornier Biofiber ScaffoldTornier, Inc.20111—
+7K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+7K100984Xylos Vessel GuardXylos Corporation20100—
+7K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+7K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+7K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+7K083898SurgimendTei Biosciences, Inc.200993
+7K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC200864