510(k) Report

Devices descending from K130857

3 later devices reach Prontosan Wound Gel X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+1K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+2K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—