K241552 is an FDA 510(k) clearance for the 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 September 6, 2024, 98 days after receiving the submission on May 31, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K241552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2024 |
| Decision Date | September 06, 2024 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |