Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K200404 |
Device Name |
ORISE ProKnife |
Applicant |
Boston Scientific Corporation |
300 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Applicant Contact |
Jennifer Edouard |
Correspondent |
Boston Scientific Corporation |
300 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Jennifer Edouard |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/19/2020 |
Decision Date | 12/03/2020 |
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
|
|
|