510(k) Report

Devices descending from K071552

11 later devices reach Puracol Plus AG Collagen Microscaffold Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240809LUOFUCON® Silver Collagen DressingHuizhou Foryou Medical Devices Co., Ltd.20240—
+1K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163—
+1K123961Sentrex Biosponge MPDBionova Medical, Inc.20134—
+1K112191Healex Biosponge Wound DressingBionova Medical, Inc.20125—
+2K222189SiOxD Wound MatrixSioxmed, LLC20222—
+2K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20223—
+3K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+3K232847SiOxD Wound MatrixSioxmed, LLC20231—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.20232—
+4K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc.20240—
+4K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.20241—