Device Classification Name |
snare, flexible
|
510(k) Number |
K172729 |
Device Name |
Polypectomy Snare |
Applicant |
Hangzhou AGS MedTech CO., Ltd |
Building 6, Kangxin Road No.597 |
Qianjiang Economic Development Area |
Hangzhou,
CN
311106
|
|
Applicant Contact |
Chunqi Han |
Correspondent |
Shanghai Thinkwell Consulting Co., Ltd. |
Xinling Rd, 211/6F |
Shanghai,
CN
201100
|
|
Correspondent Contact |
Ethan Liu |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 09/11/2017 |
Decision Date | 05/21/2018 |
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
|
|
|