LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD— 510(k) K951328

Substantially Equivalent

Labeltape Meditect, Inc.

FDA 510(k) clearance K951328 for LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD, Substantially Equivalent on 1995-04-25. Applicant: Labeltape Meditect, Inc..

Clearance details

Applicant: Labeltape Meditect, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1995-03-23
Decision date: 1995-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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.