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

Name: FDA 510(k) clearance K152642
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

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. Device class: 2.

Clearance details

Applicant: Lccs Products Limited
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
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 ↗

Recent devices under product code GXI

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K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

More clearances from Lccs Products Limited

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K191293 — LCCS VC-S RF Cannula2020-01-24
K131006 — ANESTHESIA CONDUCTION NEEDLES2013-12-06
K132136 — SINGLE USE GROUNDING PAD2013-09-06
K112231 — LCCS INSULATED SPINAL NEEDLE (RF CANNULA)2011-08-19

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.