510(k) Report

Devices descending from K070303

3 later devices reach Silicone Tissue Expander through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLC20230—
+1K140383ALLOX2 Tissue ExpandersSpecialty Surgical Products, Inc.20141—
+2K214124AlloX2 Pro Tissue ExpandersSientra, Inc.20230—