LCCS Disposable RF Electrode, LCCS Reusable RF Electrode— 510(k) K152642

Substantially Equivalent

Lccs Products Limited

FDA 510(k) clearance K152642 for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode, Substantially Equivalent on 2016-08-26. Applicant: Lccs Products Limited.

Clearance details

Applicant: Lccs Products Limited
Product code: 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

Download summary PDF View on FDA.gov ↗

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.