K200260 is an FDA 510(k) clearance for the Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 26, 2021, 448 days after receiving the submission on February 3, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K200260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 03, 2020 |
| Decision Date | April 26, 2021 |
| Days to Decision | 448 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 |