The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd with the FDA for Polypectomy Snare.
| Device ID | K172729 |
| 510k Number | K172729 |
| Device Name: | Polypectomy Snare |
| Classification | Snare, Flexible |
| Applicant | Hangzhou AGS MedTech CO., Ltd Building 6, Kangxin Road No.597 Qianjiang Economic Development Area Hangzhou, CN 311106 |
| Contact | Chunqi Han |
| Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd, 211/6F Shanghai, CN 201100 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-11 |
| Decision Date | 2018-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849771039112 | K172729 | 000 |
| 16959664901929 | K172729 | 000 |
| 16959664910969 | K172729 | 000 |
| 16959664910983 | K172729 | 000 |
| 16959664911843 | K172729 | 000 |
| 16959664911850 | K172729 | 000 |
| 10849771038969 | K172729 | 000 |
| 00849771038986 | K172729 | 000 |
| 00849771039006 | K172729 | 000 |
| 00849771039044 | K172729 | 000 |
| 00849771039075 | K172729 | 000 |
| 00849771039099 | K172729 | 000 |
| 16959664901905 | K172729 | 000 |