ClearanceBrief
Panels › Neurology › Product code GXI · Class 2

Probe, Radiofrequency Lesion

Regulation 882.4725

2510(k)s in 12 months (66 all time)
3recalls in 12 months (29 all time)
29recalls that name a 510(k)
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Top companies in GXI

Company510(k)sRecalls
Baylis Medical Co., Inc.72
Boston Scientific Neuromodulation Corporation08
Relievant Medsystems60
Cosman Medical, Inc.41
Diros Technology, Inc.50
Medtronic Sofamor Danek USA Inc05
Epimed International, Inc.22
Smith & Nephew, Inc.40
ABBOTT MEDICAL21
Advanced Surgical Products, Inc.30
Decided510(k)Device and applicantCode
Apr 16, 2026K253907Disposable Radiofrequency Cannula
ABBOTT MEDICAL
GXI
Feb 13, 2026K251802STAR RF Ablation System
Merit Medical Systems, Inc.
GXI
Aug 15, 2025K251243OneRF Trigeminal Nerve Radiofrequency Probes
Neuroone Medical Technologies Corp.
GXI
May 27, 2025K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
ABBOTT MEDICAL
GXI
May 15, 2025K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation Syst
Stryker Instruments
GXI
Jan 23, 2025K241367RF Cannula
Shanghai Samedical & Plastic Instruments Co., Ltd., CN
GXI
Oct 26, 2022K222281Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc.
GXI
Mar 11, 2022K213836Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc.
GXI
Dec 22, 2020K203066COOLIEF Cooled Radiofrequency Kit Advanced
Avanos Medical, Inc.
GXI
Feb 7, 2020K190259Vesta RF Cannula
Biomerics
GXI
Jan 24, 2020K191293LCCS VC-S RF Cannula
Lccs Products Limited, CN
GXI
May 3, 2019K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instrument
Relievant Medsystems
GXI
Mar 8, 2019K190256Rulo Radiofrequency Lesion Probe
Epimed International, Inc.
GXI
Mar 8, 2019K183177Nitinol Thermocouple (TCN) Electrode
Boston Scientific Corporation
GXI
Sep 14, 2018K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
Relievant Medsystems
GXI
Aug 9, 2017K170827INTRACEPT Intraosseous Nerve Ablation System
Relievant Medsystems
GXI
Jun 27, 2017K170708OWL RF INSULATED CANNULAE
Diros Technology, Inc., CA
GXI
Apr 13, 2017K163461Coolief* Cooled RF Probe
Halyard Health, Inc.
GXI
Dec 16, 2016K163236COOLIEF Cooled Radiofrequency Kit
Halyard Health, Inc.
GXI
Aug 26, 2016K152642LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
Lccs Products Limited, CN
GXI
Jul 9, 2016K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
Relievant Medsystems
GXI
Jul 30, 2015K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
Diros Technology, Inc., CA
GXI
Dec 30, 2014K141586OWL CANNULAE
Diros Technology, Inc., CA
GXI
Mar 28, 2013K123178STRYKER VENOM ELECTRODES AND CANNULAE
Stryker Instruments, Instruments Div.
GXI
Sep 21, 2012K121773NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
Biomerics
GXI
Aug 19, 2011K112231LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
Lccs Products Limited, CN
GXI
Jun 3, 2011K102566OWL CANNULAE
Diros Technology, Inc., CA
GXI
May 5, 2011K110593OWL RF PROBES
Diros Technology, Inc., CA
GXI
Aug 10, 2010K101372DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
Baylis Medical Co., Inc., CA
GXI
Jun 14, 2010K090608MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
Minta Medical Limited, GB
GXI
Oct 16, 2009K092337PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
Baylis Medical Co., Inc., CA
GXI
Jul 16, 2009K090955SMITH & NEPHEW RF CANNULATE
Smith & Nephew, Inc.
GXI
Nov 10, 2008K080771TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
Top Corp.
GXI
Oct 14, 2008K082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
Cosman Medical, Inc.
GXI
Jul 20, 2007K071300MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
Smith & Nephew, Inc.
GXI
Jul 19, 2007K071745BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
Baylis Medical Co., Inc., CA
GXI
Feb 15, 2007K062946TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
Top Corp.
GXI
Jan 8, 2007K062937TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
Baylis Medical Co., Inc., CA
GXI
Nov 21, 2006K063467SMITH & NEPHEW RF CANNULAE
Smith & Nephew, Inc.
GXI
Aug 31, 2006K060397RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
PAJUNK GmbH Medizintechnologie, DE
GXI
May 2, 2006K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
Cosman Medical, Inc.
GXI
Apr 25, 2006K053415LESIONPOINT RF CANNULA
Cosman Medical, Inc.
GXI
Nov 30, 2005K053082BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
Baylis Medical Co., Inc., CA
GXI
May 31, 2005K043442STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
Stryker Instruments
GXI
Mar 17, 2005K050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
Cosman Medical, Inc.
GXI
Oct 26, 2004K042375SMK, CX, CXE, RCN
Technomed Europe, NL
GXI
Sep 16, 2004K041021RF INTRODUCTION CANNULA
Epimed International, Inc.
GXI
Apr 1, 2004K032406STRYKER RF ELECTRODES AND CANNULAE
Stryker Instruments
GXI
Mar 16, 2004K034012SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
Smith & Nephew, Inc.
GXI
Oct 9, 2003K032196NBD DISPOSABLE RF CANNULAE
New Business Development, LLC
GXI

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