Submission Details
| 510(k) Number | K260502 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 13, 2026 |
| Decision Date | March 12, 2026 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |