LCCS VC-S RF Cannula— 510(k) K191293

Name: FDA 510(k) clearance K191293
Creator: U.S. Food and Drug Administration
Published: 2020-01-24

Substantially Equivalent

Lccs Products Limited

FDA 510(k) clearance K191293 for LCCS VC-S RF Cannula, Substantially Equivalent on 2020-01-24. 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: 2019-05-14
Decision date: 2020-01-24
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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K253907 — Disposable Radiofrequency Cannula2026-04-16
K251802 — STAR RF Ablation System2026-02-13
K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
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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K152642 — LCCS Disposable RF Electrode, LCCS Reusable RF Electrode2016-08-26
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.