K851251 is an FDA 510(k) clearance for the AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on July 2, 1985, 97 days after receiving the submission on March 27, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K851251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1985 |
| Decision Date | July 02, 1985 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |