K243271 is an FDA 510(k) clearance for the MENTOR? MemoryShape? Resterilizable Gel Breast Implant Sizer; MENTOR? MemoryGel? Resterilizable Gel Breast Implant Sizer; MENTOR? MemoryGel? Enhance Single Use Gel Sizer. This device is classified as a Mammary Sizer.
Submitted by Mentor Worldwide, LLC (Irvine, US). The FDA issued a Cleared decision on January 13, 2025, 89 days after receiving the submission on October 16, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2024 |
| Decision Date | January 13, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |