INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC— 510(k) K020334

Name: FDA 510(k) clearance K020334
Creator: U.S. Food and Drug Administration
Published: 2002-10-03

Substantially Equivalent

Jac-Cell Medic Corporation

FDA 510(k) clearance K020334 for INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC, Substantially Equivalent on 2002-10-03. Applicant: Jac-Cell Medic Corporation. Device class: 2.

Clearance details

Applicant: Jac-Cell Medic Corporation
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2002-01-31
Decision date: 2002-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maineville, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.