510(k) Report

Devices descending from K091863

2 later devices reach Awbat-S Plus, Awbat-D Plus, Awbat-M Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153678PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc.20161—
+2K212579FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc.20230—