510(k) Report

Devices descending from DEN150055

2 later devices reach AeroForm Tissue Expander System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170075AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Airxpanders, Inc.20171—
+2K191138AeroForm Tissue Expander, SmoothAirxpanders, Inc.20190—