510(k) Report

Devices descending from K150777

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161176ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC201622
+2K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC20250—
+2K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC20250—