K201436 is an FDA 510(k) clearance for the Vortek Single Loop Ureteral Stent, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on February 25, 2021, 269 days after receiving the submission on June 1, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K201436 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2020 |
| Decision Date | February 25, 2021 |
| Days to Decision | 269 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 |