MEDICALEX— 510(k) K833377

Name: FDA 510(k) clearance K833377
Creator: U.S. Food and Drug Administration
Published: 1984-09-27

Substantially Equivalent

Medicalex

FDA 510(k) clearance K833377 for MEDICALEX, Substantially Equivalent on 1984-09-27. Applicant: Medicalex. Device class: 1.

Clearance details

Applicant: Medicalex
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-09-29
Decision date: 1984-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.