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 Baylis Medical Co., Inc., Diros Technology, Inc. and Smith & Nephew, Inc..

66
Total
66
Cleared
132d
Avg days
1980
Since
66 devices
25–48 of 66
Cleared Sep 21, 2012
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773
Biomerics
Neurology · 95d
Cleared Aug 19, 2011
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
K112231
Lccs Products Limited
Neurology · 15d
Cleared Jun 03, 2011
OWL CANNULAE
K102566
Diros Technology, Inc.
Neurology · 269d
Cleared May 05, 2011
OWL RF PROBES
K110593
Diros Technology, Inc.
Neurology · 64d
Cleared Aug 10, 2010
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372
Baylis Medical Co., Inc.
Neurology · 85d
Cleared Jun 14, 2010
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
K090608
Minta Medical Limited
Neurology · 465d
Cleared Oct 16, 2009
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337
Baylis Medical Co., Inc.
Neurology · 73d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955
Smith & Nephew, Inc.
Neurology · 101d
Cleared Nov 10, 2008
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771
Top Corp.
Neurology · 236d
Cleared Oct 14, 2008
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
K082012
Cosman Medical, Inc.
Neurology · 91d
Cleared Jul 20, 2007
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K071300
Smith & Nephew, Inc.
Neurology · 72d
Cleared Jul 19, 2007
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745
Baylis Medical Co., Inc.
Neurology · 22d
Cleared Feb 15, 2007
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
K062946
Top Corp.
Neurology · 140d
Cleared Jan 08, 2007
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
K062937
Baylis Medical Co., Inc.
Neurology · 102d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467
Smith & Nephew, Inc.
Neurology · 28d
Cleared Aug 31, 2006
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397
PAJUNK GmbH Medizintechnologie
Neurology · 197d
Cleared May 02, 2006
COSMAN CSK RF CANNULA
K060799
Cosman Medical, Inc.
Neurology · 39d
Cleared Apr 25, 2006
LESIONPOINT RF CANNULA
K053415
Cosman Medical, Inc.
Neurology · 139d
Cleared Nov 30, 2005
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K053082
Baylis Medical Co., Inc.
Neurology · 28d
Cleared May 31, 2005
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442
Stryker Instruments
Neurology · 168d
Cleared Mar 17, 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084
Cosman Medical, Inc.
Neurology · 63d
Cleared Oct 26, 2004
SMK, CX, CXE, RCN
K042375
Technomed Europe
Neurology · 55d
Cleared Sep 16, 2004
RF INTRODUCTION CANNULA
K041021
Epimed International, Inc.
Neurology · 149d
Cleared Apr 01, 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406
Stryker Instruments
Neurology · 241d