K161758 is an FDA 510(k) clearance for the Weck Auto Endo10 Automatic Endoscopic Clip Applier. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on September 7, 2016, 72 days after receiving the submission on June 27, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K161758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2016 |
| Decision Date | September 07, 2016 |
| Days to Decision | 72 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 |