The following data is part of a premarket notification filed by Incore Co., Ltd. with the FDA for Core-clip.
| Device ID | K213338 |
| 510k Number | K213338 |
| Device Name: | CORE-CLIP |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Incore Co., Ltd. 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, KR 41072 |
| Contact | Jae-Hun Lee |
| Correspondent | Seon-mi Kim KMC,Inc. Room No. 1709, 123, Digital-ro 26-gil, Guro-gu Seoul, KR 08390 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-07 |
| Decision Date | 2022-06-23 |