K211676 is an FDA 510(k) clearance for the Motiva Flora SmoothSilk Tissue Expander. This device is classified as a Tissue Expander And Accessories.
Submitted by Motiva USA, LLC (Santa Barbara, US). The FDA issued a Cleared decision on October 13, 2023, 864 days after receiving the submission on June 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K211676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2021 |
| Decision Date | October 13, 2023 |
| Days to Decision | 864 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LCJ - Tissue Expander And Accessories |
| Device Class | - |