510(k) Report

Devices descending from K163062

6 later devices reach PHMB Antimicrobial Foam Wound Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181197PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd.20185—
+2K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd.20230—
+2K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam…Winner Medical Co., Ltd.20201—
+2K190819Silicone PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd.20191—
+3K223310Antimicrobial Silicone PHMB Foam Wound DressingAdvanced Medical Solutions Limited20230—
+3K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—