K053252 is an FDA 510(k) clearance for the U-CLIP DEVICE, MODELS B140, B160 AND B180. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on December 16, 2005, 25 days after receiving the submission on November 21, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K053252 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |