K242841

Substantially Equivalent

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Applicant: ABBOTT MEDICAL
Product code: GXI
Advisory panel: Neurology
Date received: 2024-09-19
Decision date: 2025-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.