Device Classification Name |
choledochoscope and accessories, flexible/rigid
|
510(k) Number |
K142922 |
FOIA Releasable 510(k) |
K142922
|
Device Name |
SpyGlass DS Direct Visualization System |
Applicant |
BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
CARTER NAVARRO |
Correspondent |
BOSTON SCIENTIFIC CORPORATION |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
CARTER NAVARRO |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/08/2014 |
Decision Date | 01/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
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
|
|
|