K213946 is an FDA 510(k) clearance for the Compass BDS Biliary Stent, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on May 9, 2022, 143 days after receiving the submission on December 17, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K213946 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 17, 2021 |
| Decision Date | May 09, 2022 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |