The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Resolution Clip.
| Device ID | K151802 |
| 510k Number | K151802 |
| Device Name: | Resolution Clip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Elena Nieves |
| Correspondent | Elena Nieves BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-08-06 |
| Summary: | summary |