K142777 is an FDA 510(k) clearance for the Weck Hem-o-lok Auto Endo5 Ligating Clip Applier. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on December 19, 2014, 84 days after receiving the submission on September 26, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K142777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2014 |
| Decision Date | December 19, 2014 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| 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 |