510(k) Report

Devices descending from K061494

26 later devices reach Dermadapt Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071425Unite BiomatrixPegasus Biologics, Inc.200725—
+2K122502Bridge Extracellular Collegen MatrixHarbor Medtech, Inc.20131—
+2K112399Unite BiomatrixSynovis Orthopedic & Woundcare20110—
+2K092096Endoform Dermal TemplateMesynthes, Ltd.2010193
+2K082103LTM Wound DressingLifecell Corp.20087—
+3K260669Endoform Dermal TemplateAroa Biosurgery, Ltd.20260—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K200502Myriad ParticlesAroa Biosurgery, Ltd.20214—
+3K171231Endoform Topical MatrixAroa Biosurgery20173—
+3K140367Architect PX Extracellular Collagen MatrixHarbor Medtech, Inc.20140—
+3K132343Marigen Wound DressingKerecis Limited20135—
+3K113866Porcine Dermal Xenografts Porcine Dermal MatrixBrennen Medical, LLC20120—
+3K101546Endoform Dental TemplateMesynthes, Ltd.20100—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K231325Corplex P / Theracor P / Allacor PStimlabs, LLC20243—
+4K200413SymphonyAroa Biosurgery, Ltd.20202—
+4K190528MariGen Wound ExtraKerecis Limited20193—
+4K153364Kerecis SecureMeshKerecis Limited20160—
+5K253204CatalyzeBioTissue Holdings, Inc.20260—
+5K252673LacertaMatrixLacerta Life Science20251—
+5K253339TheracorStimlabs, LLC20250—
+5K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+5K242828Corplex P/ Theracor P/ Allacor PStimlabs, LLC20240—
+5K241080Kerecis Parvus (50207)Kerecis Limited20241—
+5K213231Kerecis SiliconeKerecis Limited20221—
+6K260218LacertaMatrixLacerta Life Sciences20260—