The following data is part of a premarket notification filed by W.l. Gore & Associates Inc, Medical Products Div. with the FDA for Gore Viabil Bililary Endoprosthesis.
| Device ID | K081184 |
| 510k Number | K081184 |
| Device Name: | GORE VIABIL BILILARY ENDOPROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. 3250 WEST KILTIE LN. Flagstaff, AZ 86002 -0500 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. 3250 WEST KILTIE LN. Flagstaff, AZ 86002 -0500 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132615834 | K081184 | 000 |
| 00733132615537 | K081184 | 000 |
| 00733132615520 | K081184 | 000 |
| 00733132615513 | K081184 | 000 |
| 00733132615506 | K081184 | 000 |
| 00733132615490 | K081184 | 000 |
| 00733132615483 | K081184 | 000 |
| 00733132615476 | K081184 | 000 |
| 00733132615469 | K081184 | 000 |
| 00733132615452 | K081184 | 000 |
| 00733132615445 | K081184 | 000 |
| 00733132615438 | K081184 | 000 |
| 00733132615421 | K081184 | 000 |
| 00733132615551 | K081184 | 000 |
| 00733132615575 | K081184 | 000 |
| 00733132615810 | K081184 | 000 |
| 00733132615797 | K081184 | 000 |
| 00733132615773 | K081184 | 000 |
| 00733132615759 | K081184 | 000 |
| 00733132615735 | K081184 | 000 |
| 00733132615711 | K081184 | 000 |
| 00733132615698 | K081184 | 000 |
| 00733132615674 | K081184 | 000 |
| 00733132615650 | K081184 | 000 |
| 00733132615636 | K081184 | 000 |
| 00733132615612 | K081184 | 000 |
| 00733132615599 | K081184 | 000 |
| 00733132615414 | K081184 | 000 |