Device Classification Name |
choledochoscope and accessories, flexible/rigid
|
510(k) Number |
K183636 |
Device Name |
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller |
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 | 12/26/2018 |
Decision Date | 01/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|