510(k) Report

Devices descending from K143058

3 later devices reach PuraDerm Gel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193085PuraDERM Gel3-D Matrix, Inc.20200—
+1K182681AC5 Topical GelArch Therapeutics, Inc.20181—
+2K190129AC5 Topical GelArch Therapeutics, Inc.20200—