510(k) Report

Devices descending from K121522

5 later devices reach Polyfit Absorbing Antimicrobial Dressings (Otc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+1K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+2K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+2K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+3K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—