K151055 is an FDA 510(k) clearance for the Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE. This device is classified as a Mammary Sizer.
Submitted by Mentor Worldwide, LLC (Santa Barbara, US). The FDA issued a Cleared decision on May 20, 2015, 30 days after receiving the submission on April 20, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K151055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2015 |
| Decision Date | May 20, 2015 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |