510(k) K170740
- Device
- GORE VIABIL Short Wire Biliary Endoprosthesis
- Applicant
- W.L. Gore & Associates, Inc.
- 510(k) number
- K170740
- Product code
- FGE
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2017-05-08
- Date received
- 2017-03-10
- Regulation
- 876.5010
- Classification name
- Stents, Drains And Dilators For The Biliary Ducts
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Barbara L. Smith
- Address
- 301 Airport Rd. Elkton MD US 21921 21921
FDA Registration Numbers
- 1450395
- 3014769442
- 1061124
- 3004129994
- 3002504068
- 3014328942
- 3035451914
- 3006131984
- 2183870
- 2183744
- 1222168
- 3012536737
- 3006260740
- 2032098
- 1644312
- 2134265
- 3001845648
- 3003910212
- 3011347300
- 3030447506
- 3011050570
- 3013557562
- 9616099
- 2024168
- 2246552
- 9616684
- 1225687
- 3031276312
- 1721676
- 1820334
- 2939561
- 3033589330
- 3006950086
- 1317547
- 3005099803
- 3013162291
- 3005089785
- 2126666
- 2024024
- 3002807314
- 1018233
- 1417485
- 9710284
- 1223925
- 3021009035
- 1828132
- 3030733800
- 1037905
- 1531050
- 3013337852
- 1625425
- 3008146331
- 3013152301
- 3014279513
- 3040505963
- 3010155661
- 9680809
- 1058584
- 3011146996
- 3008040402
- 3009526575
- 3014579161
- 3007695959
- 1928237
- 1000393132
- 3012480535
- 1724474
- 1319639
- 3004091615
- 3011458193
- 9681477
- 3009763019
- 3021632375
- 9614641
- 3008492676
- 3013460719
- 2030624
- 3009018440
- 3030446844
- 3027260597
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132638895 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638888 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638871 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638864 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638857 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638840 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638833 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638826 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638819 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638802 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638796 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638789 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638772 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
| 00733132638765 | GORE VIABIL Biliary Endoprosthesis | W. L. Gore & Associates, Inc. | 2017-05-10 |
Legacy Summary
summary
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases