K152642

Substantially Equivalent

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

Applicant: Lccs Products Limited
Product code: GXI
Advisory panel: Neurology
Date received: 2015-09-15
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

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.