510(k) Report

Devices descending from K181197

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

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