The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Resolution Clip, Resolution 360 Clip, Resolution 360 Ultra Clip.
| Device ID | K222503 |
| 510k Number | K222503 |
| Device Name: | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jia Huang |
| Correspondent | Jia Huang Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-18 |
| Decision Date | 2022-09-14 |