Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K170740 |
Device Name |
GORE VIABIL Short Wire Biliary Endoprosthesis |
Applicant |
W.L. Gore & Associates, Inc. |
301 Airport Road |
Elkton,
MD
21921
|
|
Applicant Contact |
Barbara L. Smith |
Correspondent |
W.L. Gore & Associates, Inc. |
301 Airport Road |
Elkton,
MD
21921
|
|
Correspondent Contact |
Barbara L. Smith |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 03/10/2017 |
Decision Date | 05/08/2017 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|