K251469 is an FDA 510(k) clearance for the Endura™ Ureteral Stent and Stent Set. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Cathegenix (Xiamen) Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on December 19, 2025, 220 days after receiving the submission on May 13, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K251469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 13, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAD - Stent, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4620 |