K131853 is an FDA 510(k) clearance for the MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER. This device is classified as a Mammary Sizer.
Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on July 17, 2013, 26 days after receiving the submission on June 21, 2013.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K131853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2013 |
| Decision Date | July 17, 2013 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |