The following data is part of a premarket notification filed by Finemedix Co., Ltd. with the FDA for Clearendoclip.
| Device ID | K200217 |
| 510k Number | K200217 |
| Device Name: | ClearEndoclip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Finemedix Co., Ltd. 60, Maeyeo-ro, Dong-gu Daegu, KR 41065 |
| Contact | H. S. Lee |
| Correspondent | Kyungyoon Kang K-Bio Solutions 589 Oakwood Drive Santa Clara, CA 95054 |
| Product Code | PKL |
| Subsequent Product Code | FHN |
| Subsequent Product Code | MND |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18809327353092 | K200217 | 000 |
| 18809327353085 | K200217 | 000 |