Device Classification Name |
Forceps, Biopsy, Electric
|
510(k) Number |
K202438 |
Device Name |
Ensure Single-Use Coagulation Forceps |
Applicant |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Thrid Road |
Nanjing,
CN
210032
|
|
Applicant Contact |
Cecilia Sun |
Correspondent |
Micro-Tech (Nanjing) Co., Ltd. |
No. 10 Gaoke Third Road |
Nanjing,
CN
210032
|
|
Correspondent Contact |
Cecilia Sun |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 08/25/2020 |
Decision Date | 03/15/2021 |
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
|
|
|