510(k) Report

Devices descending from K896110

54 later devices reach Biobrane (R) II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021792Bilayer Matrix Wound DressingIntegra Lifesciences Corp.2002531
+2K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+2K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+2K090823Theraform BilayerSewon Cellontech Co., Ltd.20090—
+2K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+2K081635Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp.200810—
+2K081724Hydrolyzed Collagen with 10% Chondroitin Sulfate (Psgag, Polysulfated Glycosaminoglycan)…Applied Nutritionals20080—
+2K073251Hyalomatrix PAFidia Advanced Biopolymers Srl200721
+3K261311HyalomatrixAnika Therapeutics, Inc.20260—
+3K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K213498PELNAC Meshed Bilayer Wound MatrixGunze Limited20220—
+3K210135PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing3M Healthcare Business Group20221—
+3K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+3K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+3K171231Endoform Topical MatrixAroa Biosurgery20173—
+3K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+3K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+3K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+3K112568Aongen Dental Collagen MatrixAeon Astron Europe B.V.20120—
+3K102946Coreleader Colla-Pad Model CS 03030Coreleader Biotech Co., Ltd.20110—
+3K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+3K092257JaloskinFidia Advanced Biopolymers Srl20100—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+4K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH20260—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+4K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+4K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+4K222189SiOxD Wound MatrixSioxmed, LLC20222—
+4K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K193583Restrata®Acera Surgical, Inc.202011
+4K200413SymphonyAroa Biosurgery, Ltd.20202—
+5K253204CatalyzeBioTissue Holdings, Inc.20260—
+5K252673LacertaMatrixLacerta Life Science20251—
+5K253339TheracorStimlabs, LLC20250—
+5K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+5K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+5K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+5K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+5K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K260218LacertaMatrixLacerta Life Sciences20260—