K200706 is an FDA 510(k) clearance for the Sientra OPUS Silicone Gel Breast Implant Sizer. This device is classified as a Mammary Sizer.
Submitted by Sientra, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on November 16, 2020, 243 days after receiving the submission on March 18, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K200706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2020 |
| Decision Date | November 16, 2020 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD - Mammary Sizer |
| Device Class | - |