510(k) Report

Devices descending from K990086

85 later devices reach Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110318ExcellagenTissue Repair Company20110—
+1K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918—
+1K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+1K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.200621—
+1K040283BiopadEuroresearch Srl200528—
+1K040314HealicollEncoll Corp.20040—
+1K030774Stimulen CollagenSouthwest Technologies, Inc.2004291
+1K030921Collagen Topical Wound DressingCollagen Matrix, Inc.200328—
+2K253140CollOvine™ Wound PowderOvigenex, LLC20260—
+2K213341Fibrillar Collagen Wound DressingCollagen Matrix, Inc.20220—
+2K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+2K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+2K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+2K140456Bio-Connekt Wound MatrixMLM Biologics, Inc.20140—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+2K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081—
+2K061494Dermadapt Wound DressingPegasus Biologics, Inc.200626—
+2K061474Collawound DressingCollamatrix Co., Inc.20063—
+2K060888Acell Powder Wound DressingAcell, Inc.20065—
+2K040403Collagen Wound Dressing - OralCollagen Matrix, Inc.200410—
+2K040558Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc.200413—
+2K040211Modification to: Collagen Topical Wound DressingCollagen Matrix, Inc.200414—
+3K243071Bovine Dermis Collagen Dermal MatrixCollagen Matrix, Inc.20240—
+3K172593XCelliStem Wound PowderStemsys20181—
+3K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+3K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K153754MicroMatrixAcell, Inc.20160—
+3K142712Dental Collagen Wound Dressing (Nova Tape and NovaPlug)Novabone Products, LLC20150—
+3K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp.20140—
+3K122115Collagen Dental Wound DressingsCollagen Matrix, Inc.20125—
+3K110388Collacare DentalInnocoll Pharmaceuticals, Ltd.20116—
+3K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+3K071425Unite BiomatrixPegasus Biologics, Inc.200725—
+3K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals200612—
+4K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+4K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+4K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K193583Restrata®Acera Surgical, Inc.202011
+4K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+4K152600Collagen Dental Wound DressingsCollagen Matrix, Inc.201621
+4K133290Collacare DentalInnocoll Pharmaceuticals20141—
+4K122502Bridge Extracellular Collegen MatrixHarbor Medtech, Inc.20131—
+4K112399Unite BiomatrixSynovis Orthopedic & Woundcare20110—
+4K092805Collagen SpongeInnocoll Pharmaceuticals201010—
+4K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+4K082103LTM Wound DressingLifecell Corp.20087—
+4K081782CollievaInnocoll Pharmaceuticals200811—
+5K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+5K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)20250—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+5K230529HealiAid Dental Collagen Wound DressingMaxigen Biotech, Inc.20230—
+5K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+5K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+5K171231Endoform Topical MatrixAroa Biosurgery20173—
+5K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+5K132343Marigen Wound DressingKerecis Limited20135—
+5K120339ProcollInnocoll Pharmaceuticals20120—
+5K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+5K103648Collagen PowderInnocoll Pharmaceuticals, Ltd.20110—
+5K100574CollexaInnocoll Pharmaceuticals20100—
+5K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+6K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+6K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+6K200413SymphonyAroa Biosurgery, Ltd.20202—
+6K190528MariGen Wound ExtraKerecis Limited20193—
+6K153364Kerecis SecureMeshKerecis Limited20160—
+7K253204CatalyzeBioTissue Holdings, Inc.20260—
+7K252673LacertaMatrixLacerta Life Science20251—
+7K253339TheracorStimlabs, LLC20250—
+7K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+7K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+7K241080Kerecis Parvus (50207)Kerecis Limited20241—
+7K213231Kerecis SiliconeKerecis Limited20221—
+8K260218LacertaMatrixLacerta Life Sciences20260—