K243830 is an FDA 510(k) clearance for the Disposable ureteral stent. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2025, 152 days after receiving the submission on December 13, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K243830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | May 14, 2025 |
| Days to Decision | 152 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 |