ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD— 510(k) K940299

Substantially Equivalent

Debusk Technology Corp.

FDA 510(k) clearance K940299 for ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD, Substantially Equivalent on 1994-05-02. Applicant: Debusk Technology Corp..

Clearance details

Applicant: Debusk Technology Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1994-01-21
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

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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.