K183163 is an FDA 510(k) clearance for the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix. This device is classified as a Mammary Sizer.
Submitted by Motiva USA, LLC (New York, US). The FDA issued a Cleared decision on February 5, 2019, 82 days after receiving the submission on November 15, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K183163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2018 |
| Decision Date | February 05, 2019 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |