GXI · Class II · 21 CFR 882.4725

FDA Product Code GXI: Probe, Radiofrequency Lesion

Under FDA product code GXI, radiofrequency lesion probes are cleared for creating precise thermal lesions in neural tissue for pain management and movement disorder treatment.

These electrodes deliver controlled radiofrequency energy to create a coagulative lesion at a specific neural target — interrupting pain pathways or abnormal motor circuits. They are used in trigeminal neuralgia, cancer pain, and movement disorder surgery.

GXI devices are Class II medical devices, regulated under 21 CFR 882.4725 and reviewed by the FDA Neurology panel.

Leading manufacturers include Smith & Nephew, Inc., Relievant Medsystems and Relievant Medsystems, Inc..

66
Total
66
Cleared
132d
Avg days
1980
Since
Growing category - 6 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 185d recently vs 126d historically

FDA 510(k) Cleared Probe, Radiofrequency Lesion Devices (Product Code GXI)

66 devices
1–24 of 66
Cleared Apr 16, 2026
Disposable Radiofrequency Cannula
K253907
Abbott Medical
Neurology · 132d
Cleared Feb 13, 2026
STAR RF Ablation System
K251802
Merit Medical Systems, Inc.
Neurology · 246d
Cleared Aug 15, 2025
OneRF Trigeminal Nerve Radiofrequency Probes
K251243
Neuroone Medical Technologies Corp.
Neurology · 115d
Cleared May 27, 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841
Abbott Medical
Neurology · 250d
Cleared May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213
Stryker Instruments
Neurology · 111d
Cleared Jan 23, 2025
RF Cannula
K241367
Shanghai Samedical & Plastic Instruments Co., Ltd.
Neurology · 254d
Cleared Oct 26, 2022
Intracept Intraosseous Nerve Ablation System
K222281
Relievant Medsystems, Inc.
Neurology · 89d
Cleared Mar 11, 2022
Intracept Intraosseous Nerve Ablation System
K213836
Relievant Medsystems, Inc.
Neurology · 92d
Cleared Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
K203066
Avanos Medical, Inc.
Neurology · 74d
Cleared Feb 07, 2020
Vesta RF Cannula
K190259
Biomerics
Neurology · 365d
Cleared Jan 24, 2020
LCCS VC-S RF Cannula
K191293
Lccs Products Limited
Neurology · 255d
Cleared May 03, 2019
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
K190504
Relievant Medsystems
Neurology · 63d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177
Boston Scientific Corporation
Neurology · 112d
Cleared Mar 08, 2019
Rulo Radiofrequency Lesion Probe
K190256
Epimed International, Inc.
Neurology · 29d
Cleared Sep 14, 2018
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369
Relievant Medsystems
Neurology · 214d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955
Smith & Nephew, Inc.
Neurology · 101d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300
Smith & Nephew, Inc.
Neurology · 72d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467
Smith & Nephew, Inc.
Neurology · 28d
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012
Smith & Nephew, Inc.
Neurology · 83d

About Product Code GXI - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code GXI since 1980, with 66 receiving FDA clearance (average review time: 132 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - GXI Product Code

Recent submissions under GXI have taken an average of 185 days to reach a decision - up from 126 days historically. Manufacturers should account for longer review timelines in current project planning.

GXI devices are reviewed by the Neurology panel. Browse all Neurology devices →