510(k) Report

Devices descending from K010709

7 later devices reach Mentor Sterile Saline Mammary Volume Sizers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062421Mentor Resterilizable Gel Breast Implant SizerMentor Corporation200661
+2K241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLC20241—
+2K131853Mentor Memoryshape Resterilizable Gel SizerMentor Worldwide, LLC20134—
+3K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™…Mentor Worldwide, LLC20250—
+3K151055Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILEMentor Worldwide, LLC20153—
+4K183163Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMotiva USA, LLC20191—
+5K200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.20200—