K051125 is an FDA 510(k) clearance for the IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Abbott Laboratories (Redwood, US). The FDA issued a Cleared decision on June 8, 2005, 36 days after receiving the submission on May 3, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K051125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2005 |
| Decision Date | June 08, 2005 |
| Days to Decision | 36 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 |