510(k) Report

Devices descending from K161176

2 later devices reach ARTOURA Breast Tissue Expanders with Smooth Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC20250—
+1K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLC20250—