K152081 is an FDA 510(k) clearance for the Weck Auto Endo5 Hem-o-lok Ligating Clip Applier. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 26, 2015, 30 days after receiving the submission on July 27, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K152081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2015 |
| Decision Date | August 26, 2015 |
| Days to Decision | 30 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 |