K181971 is an FDA 510(k) clearance for the Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 23, 2019, 273 days after receiving the submission on July 24, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K181971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 24, 2018 |
| Decision Date | April 23, 2019 |
| Days to Decision | 273 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 |