510(k) Report

Devices descending from K993948

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+1K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+1K040314HealicollEncoll Corp.20040—
+1K023778DressskinTei Biosciences, Inc.200331—
+1K022854Acell Ubm Hydrated Wound DressingAcell, Inc.20020—
+1K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.200245—
+1K022127Avagen Wound DressingIntegra Lifesciences Corp.200228—
+1K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.2002531
+1K020732SS MatrixCook Biotech, Inc.20025—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173—
+2K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+2K241904DermiSphere Dermal TemplateFesariustherapeutics, Inc.20250—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K213573PELNAC Wound MatrixGunze Limited20220—
+2K210128INTEGRA Wound Matrix (Macro-Channels)Integra LifeSciences Corporation20210—
+2K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+2K191992PELNAC Bilayer Wound MatrixGunze Limited20200—
+2K171231Endoform Topical MatrixAroa Biosurgery20173—
+2K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+2K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+2K140820Xenomem Wound MatrixViscus Biologics, LLC20150—
+2K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.20135—
+2K113104Integra Wound Matrix (Thin)Integra LifeSciences Corporation20120—
+2K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc.201063
+2K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+2K092926Acell Matristem Wound SheetAcell, Inc.200914—
+2K090823Theraform BilayerSewon Cellontech Co., Ltd.20090—
+2K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082—
+2K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.200810—
+2K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+2K073251Hyalomatrix PAFidia Advanced Biopolymers Srl200721
+2K072113Integra Flowable Wound Matrix, Model FWD301Integra Lifesciences Corp.200751
+2K070557MP 719Marine Polymer Technologies, Inc.20072—
+2K061892Propatch Soft Tissue Repair MatrixCryolife, Inc.200617—
+2K061474Collawound DressingCollamatrix Co., Inc.20063—
+2K061407Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.200627—
+2K060888Acell Powder Wound DressingAcell, Inc.20065—
+2K052830SportmeshArtimplant AB200644—
+2K043388Pegasus Biologics Orthadapt Surgical MeshPegasus Biologics, Inc.200549—
+2K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+2K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc.200339—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200391—
+2K031188OrthomendTei Biosciences, Inc.200336—
+2K021056PermacolTissue Science Laboratories, Plc200251—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002102—
+3K261311HyalomatrixAnika Therapeutics, Inc.20260—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K250329GeniPhys Collymer Self-Assembling ScaffoldGeniphys, Inc.20250—
+3K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+3K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+3K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+3K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+3K200413SymphonyAroa Biosurgery, Ltd.20202—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K173143Phasix ST MeshC.R. Bard, Inc.20181—
+3K172593XCelliStem Wound PowderStemsys20181—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K172318Endoform Silver Dermal TemplateAroa Biosurgery20170—
+3K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+3K170364Collagen Meniscus Implant XLIvy Sports Medicine, LLC20171—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.20175—
+3K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+3K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K153754MicroMatrixAcell, Inc.20160—
+3K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc.201644
+3K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc.20153—
+3K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+3K134037PremviaBiotime, Inc.20140—
+3K130326Tephaflex Meltblown ConstructTepha, Inc.20130—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+3K120605Permacol Surgical ImplantCovidien, LLC20124—
+3K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+3K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare20120—
+3K110318ExcellagenTissue Repair Company20110—
+3K112409Matristem Wound MatrixAcell, Inc.20117—
+3K111524MP 719Marine Polymer Technologies, Inc.20110—
+3K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+3K101587Propatch Soft Tissue Repair MatrixCryolife, Inc.20102—
+3K102002TalymedMarine Polymer Technologies20100—
+3K094061Kensey Nash Ecm Surgical PatchKensey Nash Corporation201010—
+3K092257JaloskinFidia Advanced Biopolymers Srl20100—
+3K090271Hydrocoat MeshPromethean Surgical Devices, Inc.20106—
+3K090812Theraform Standard/SheetSewon Cellontech Co., Ltd.20095—
+3K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+3K090288Orthadapt PRPegasus Biologics, Inc.20097—
+3K083266Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc.200912—
+3K083307Synthasome X-RepairSynthasome, Inc.20099—
+3K083823Securian Tissue Reinforcement MatrixXylos Corporation20099—
+3K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc.200820—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071986LTM-RC Surgical MeshLifecell Corp.20073—
+3K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB200728—
+3K071016Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.200713—