K053454 is an FDA 510(k) clearance for the RX HERCULINK ELITE BILIARY STENT SYSTEM, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Guidant Corporation (S,Mta Clara, US). The FDA issued a Cleared decision on March 6, 2006, 87 days after receiving the submission on December 9, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K053454 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | December 09, 2005 |
| Decision Date | March 06, 2006 |
| Days to Decision | 87 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 |