K213444 is an FDA 510(k) clearance for the RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Ureteral Stent Company (Chagrin Falls, US). The FDA issued a Cleared decision on March 17, 2022, 143 days after receiving the submission on October 25, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K213444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2021 |
| Decision Date | March 17, 2022 |
| Days to Decision | 143 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 |