The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Single Use Hemoclip.
| Device ID | K172762 |
| 510k Number | K172762 |
| Device Name: | Single Use Hemoclip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Contact | Lucius Long |
| Correspondent | Lucius Long Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2018-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26970401813890 | K172762 | 000 |
| 26970401813715 | K172762 | 000 |
| 26970401813197 | K172762 | 000 |
| 26970401813296 | K172762 | 000 |
| 06970401811212 | K172762 | 000 |
| 26970401813166 | K172762 | 000 |
| 26970401812862 | K172762 | 000 |
| 16970401815798 | K172762 | 000 |
| 16970401815361 | K172762 | 000 |