The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for U-clip Device.
| Device ID | K062821 |
| 510k Number | K062821 |
| Device Name: | U-CLIP DEVICE |
| Classification | Clip, Implantable |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-20 |
| Decision Date | 2006-12-19 |
| Summary: | summary |