Cleared Special

Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)

K230480 · Teleflex Medical · General & Plastic Surgery
Apr 2023
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K230480 is an FDA 510(k) clearance for the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), 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 review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K230480 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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