510(k) Report

Devices descending from K090160

18 later devices reach Suprathel Wound and Burn Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173544Phoenix Wound MatrixNanofiber Solutions, Inc.20180—
+1K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH20170—
+1K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.20155—
+1K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.201410—
+2K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd.20174—
+2K170300Restrata Wound MatrixAcera Surgical, Inc.201741
+2K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+3K254256LUOFUCON® Wound MatrixHuizhou Foryou Medical Devices Co., Ltd.20260—
+3K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+3K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.20250—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+3K223725Restrata® MiniMatrixAcera Surgical, Inc.20230—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K193583Restrata®Acera Surgical, Inc.202011
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—