Device Classification Name |
Choledochoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K200483 |
FOIA Releasable 510(k) |
K200483
|
Device Name |
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller |
Applicant |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Applicant Contact |
Inderdeep Tiwana |
Correspondent |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Inderdeep Tiwana |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/27/2020 |
Decision Date | 05/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|