K053459 is an FDA 510(k) clearance for the OMNILINK .035 BILIARY STENT SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Guidant Corporation (Temecula, US). The FDA issued a Cleared decision on April 12, 2006, 120 days after receiving the submission on December 13, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K053459 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | December 13, 2005 |
| Decision Date | April 12, 2006 |
| Days to Decision | 120 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 |