510(k) Report

Devices descending from K082296

6 later devices reach Copa Amd through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201016LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound…Huizhou Foryou Medical Devices Co., Ltd.20210—
+1K160872PolyPlex Wound DressingGlobal Health Solutions, LLC20164—
+2K183681Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics)20190—
+2K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…Winner Medical Co., Ltd.20191—
+2K171191Hexagen DermGlobal Health Solutions, LLC20170—
+3K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd.20230—