K062264 is an FDA 510(k) clearance for the COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on November 8, 2007, 461 days after receiving the submission on August 4, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K062264 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | August 04, 2006 |
| Decision Date | November 08, 2007 |
| Days to Decision | 461 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 |