K203229 is an FDA 510(k) clearance for the NATRELLE INSPIRA Single Use Sizers for Gel Implants. This device is classified as a Mammary Sizer.
Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on June 2, 2021, 212 days after receiving the submission on November 2, 2020.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K203229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | June 02, 2021 |
| Days to Decision | 212 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MRD — Mammary Sizer |
| Device Class | — |