510(k) Report

Devices descending from K213163

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250109TYBR Collagen GelTybr Health20250—
+1K240817VersaWrapAlafair Biosciences, Inc.20241—
+2K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences20250—