510(k) Report

Devices descending from K021637

45 later devices reach Acell Ubm Lyophilized Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+1K092926Acell Matristem Wound SheetAcell, Inc.200914—
+1K061474Collawound DressingCollamatrix Co., Inc.20063—
+1K060888Acell Powder Wound DressingAcell, Inc.20065—
+1K040621Acell Ubm Surgical MeshAcell, Inc.20045—
+2K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+2K172593XCelliStem Wound PowderStemsys20181—
+2K171231Endoform Topical MatrixAroa Biosurgery20173—
+2K153754MicroMatrixAcell, Inc.20160—
+2K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.20153—
+2K132343Marigen Wound DressingKerecis Limited20135—
+2K112409Matristem Wound MatrixAcell, Inc.20117—
+2K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+2K090894Collawound Wound DressingCollamatrix Co., Inc.20092—
+2K080868Aongen Collagen MatrixAeon Astron Europe B.V.20091—
+2K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.20044—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K232204ReyaGel (RG03 - MTP gel 3mL)Fettech20240—
+3K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+3K200413SymphonyAroa Biosurgery, Ltd.20202—
+3K190528MariGen Wound ExtraKerecis Limited20193—
+3K181330NeoMatriX Wound MatrixNextgen Biologics, Inc.20181—
+3K173223ologen Collagen MatrixAeon Astron Europe B.V.20180—
+3K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd.20171—
+3K162554Gentrix Surgical MatrixAcell, Inc.20162—
+3K153364Kerecis SecureMeshKerecis Limited20160—
+3K152721Cytal Wound MatrixAcell, Inc.201565
+4K253204CatalyzeBioTissue Holdings, Inc.20260—
+4K252673LacertaMatrixLacerta Life Science20251—
+4K253339TheracorStimlabs, LLC20250—
+4K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+4K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd.20240—
+4K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+4K241080Kerecis Parvus (50207)Kerecis Limited20241—
+4K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc.20240—
+4K213231Kerecis SiliconeKerecis Limited20221—
+4K213607Geistlich Wound Matrix PLUSGeistlich Pharma AG20220—
+4K210024NeoMatriX Wound MatrixNextgen Biologics, Inc.20210—
+4K192725Cytal Wound Matrix 3-LayerAcell, Inc.20191—
+4K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.20190—
+4K180776Cytal Wound ParticulateAcell, Inc.20180—
+4K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc.201702
+5K260218LacertaMatrixLacerta Life Sciences20260—