Submission Details
| 510(k) Number | K243930 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2024 |
| Decision Date | March 24, 2025 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |