510(k) Report

Devices descending from K153648

6 later devices reach Microcyn Plus Skin and Wound Hydrogel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173549BiafineValeant Pharmaceuticals20184—
+1K173896Microcyn Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.20180—
+2K251093Bonvadis®Oneness Biotech Co., Ltd.20251—
+2K232655Bonvadis®Stemcyte, Inc.20242—
+2K190342BIAFINE Topical CreamBausch Health Americas Incorporated20190—
+3K261638Bonvadis®Oneness Biotech Co., Ltd.20260—