510(k) Report

Devices descending from K170075

1 later device reach AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc.20190—