510(k) Report

Devices descending from K131853

4 later devices reach Mentor Memoryshape Resterilizable Gel Sizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™…Mentor Worldwide, LLC20250—
+1K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC20153—
+2K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC20191—
+3K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.20200—