The following data is part of a premarket notification filed by W.l. Gore & Associates, Inc. with the FDA for Gore Viabil Short Wire Biliary Endoprosthesis.
| Device ID | K170740 |
| 510k Number | K170740 |
| Device Name: | GORE VIABIL Short Wire Biliary Endoprosthesis |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | W.L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21921 |
| Contact | Barbara L. Smith |
| Correspondent | Barbara L. Smith W.L. Gore & Associates, Inc. 301 Airport Road Elkton, MD 21921 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-10 |
| Decision Date | 2017-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132638895 | K170740 | 000 |
| 00733132638772 | K170740 | 000 |
| 00733132638789 | K170740 | 000 |
| 00733132638796 | K170740 | 000 |
| 00733132638802 | K170740 | 000 |
| 00733132638819 | K170740 | 000 |
| 00733132638826 | K170740 | 000 |
| 00733132638833 | K170740 | 000 |
| 00733132638840 | K170740 | 000 |
| 00733132638857 | K170740 | 000 |
| 00733132638864 | K170740 | 000 |
| 00733132638871 | K170740 | 000 |
| 00733132638888 | K170740 | 000 |
| 00733132638765 | K170740 | 000 |