K170422 is an FDA 510(k) clearance for the BIOSOFT DUO DOUBLE LOOP URETERAL STENTS, a Stent, Ureteral (Class II — Special Controls, product code FAD), submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on November 2, 2017, 262 days after receiving the submission on February 13, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K170422 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 13, 2017 |
| Decision Date | November 02, 2017 |
| Days to Decision | 262 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 |