K081184 is an FDA 510(k) clearance for the GORE VIABIL BILILARY ENDOPROSTHESIS. This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by W.L. Gore & Associates, Inc. Medical Products Div. (Flagstaff, US). The FDA issued a Cleared decision on July 22, 2008, 88 days after receiving the submission on April 25, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K081184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | April 25, 2008 |
| Decision Date | July 22, 2008 |
| Days to Decision | 88 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 |