K230480 is an FDA 510(k) clearance for the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML). 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 April 28, 2023, 65 days after receiving the submission on February 22, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K230480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2023 |
| Decision Date | April 28, 2023 |
| Days to Decision | 65 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 |