Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)— 510(k) K230480

Name: FDA 510(k) clearance K230480
Creator: U.S. Food and Drug Administration
Published: 2023-04-28

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K230480 for Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), Substantially Equivalent on 2023-04-28. Applicant: Teleflex Medical. Device class: 2.

Clearance details

Applicant: Teleflex Medical
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2023-02-22
Decision date: 2023-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.