Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K212999 |
Device Name |
Multi-Functional Electrosurgical Knife |
Applicant |
Anrei Medical (Hangzhou) Co., Ltd. |
No. 3 Ave 8, HEDA |
Hangzhou,
CN
310018
|
|
Applicant Contact |
Huibing Yang |
Correspondent |
Anrei Medical (Hangzhou) Co., Ltd. |
No. 3 Ave 8, HEDA |
Hangzhou,
CN
310018
|
|
Correspondent Contact |
Huibing Yang |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 09/20/2021 |
Decision Date | 03/21/2022 |
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
|
|
|