510(k) Report

Devices descending from K901369

2 later devices reach Green Label Biobrane II and Red Label Biobrane II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242146BIOBRANE Temporary Wound Dressing; BIOBRANE GloveSmith & Nephew Medical Limited20240—
+1K212579FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc.20230—