510(k) Report

Devices descending from K092351

7 later devices reach Poly Fit + Absorbing and High Absorbing Antimicrobial Dressings through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122297Enluxtra Humifiber Wound DressingBasf Venture Capital America, Inc.20120—
+1K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.20125—
+2K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+2K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+3K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+3K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+4K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—