Device Classification Name |
Snare, Flexible
|
510(k) Number |
K202478 |
Device Name |
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares |
Applicant |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Applicant Contact |
Stephanie Gorman |
Correspondent |
Boston Scientific Corporation |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Stephanie Gorman |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/28/2020 |
Decision Date | 10/08/2020 |
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
|
Recalls |
CDRH Recalls
|
|
|