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Probe, Radiofrequency Lesion

FDA product code GXI · 64 cleared devices

Class 2 Neurology

Regulation: 21 CFR 882.4725
Review panel: NE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-11-12 – 2026-04-16

GXI 2026-04-16

Disposable Radiofrequency Cannula

Applicant ABBOTT MEDICAL

K number K253907

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GXI 2026-02-13

STAR RF Ablation System

Applicant Merit Medical Systems, Inc.

K number K251802

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GXI 2025-08-15

OneRF Trigeminal Nerve Radiofrequency Probes

Applicant Neuroone Medical Technologies Corp.

K number K251243

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GXI 2025-05-27

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Applicant ABBOTT MEDICAL

K number K242841

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GXI 2025-05-15

OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)

Applicant Stryker Instruments

K number K250213

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GXI 2025-01-23

RF Cannula

Applicant Shanghai Samedical & Plastic Instruments Co., Ltd.

K number K241367

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GXI 2022-10-26

Intracept Intraosseous Nerve Ablation System

Applicant Relievant Medsystems, Inc.

K number K222281

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GXI 2022-03-11

Intracept Intraosseous Nerve Ablation System

Applicant Relievant Medsystems, Inc.

K number K213836

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GXI 2020-12-22

COOLIEF Cooled Radiofrequency Kit Advanced

Applicant Avanos Medical, Inc.

K number K203066

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GXI 2020-02-07

Vesta RF Cannula

Applicant Biomerics

K number K190259

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GXI 2020-01-24

LCCS VC-S RF Cannula

Applicant Lccs Products Limited

K number K191293

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GXI 2019-05-03

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Applicant Relievant Medsystems

K number K190504

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GXI 2019-03-08

Rulo Radiofrequency Lesion Probe

Applicant Epimed International, Inc.

K number K190256

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GXI 2019-03-08

Nitinol Thermocouple (TCN) Electrode

Applicant Boston Scientific Corporation

K number K183177

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GXI 2018-09-14

Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

Applicant Relievant Medsystems

K number K180369

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GXI 2017-08-09

INTRACEPT Intraosseous Nerve Ablation System

Applicant Relievant Medsystems

K number K170827

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GXI 2017-06-27

OWL RF INSULATED CANNULAE

Applicant Diros Technology, Inc.

K number K170708

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GXI 2017-04-13

Coolief* Cooled RF Probe

Applicant Halyard Health, Inc.

K number K163461

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GXI 2016-12-16

COOLIEF Cooled Radiofrequency Kit

Applicant Halyard Health, Inc.

K number K163236

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GXI 2016-08-26

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

Applicant Lccs Products Limited

K number K152642

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GXI 2016-07-09

INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set

Applicant Relievant Medsystems

K number K153272

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GXI 2013-03-28

STRYKER VENOM ELECTRODES AND CANNULAE

Applicant Stryker Instruments, Instruments Div.

K number K123178

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GXI 2012-09-21

NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE

Applicant Biomerics

K number K121773

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GXI 2011-08-19

LCCS INSULATED SPINAL NEEDLE (RF CANNULA)

Applicant Lccs Products Limited

K number K112231

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GXI 2011-06-03

OWL CANNULAE

Applicant Diros Technology, Inc.

K number K102566

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GXI 2011-05-05

OWL RF PROBES

Applicant Diros Technology, Inc.

K number K110593

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GXI 2010-08-10

DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20

Applicant Baylis Medical Co., Inc.

K number K101372

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GXI 2010-06-14

MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)

Applicant Minta Medical Limited

K number K090608

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GXI 2009-10-16

PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS

Applicant Baylis Medical Co., Inc.

K number K092337

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GXI 2009-07-16

SMITH & NEPHEW RF CANNULATE

Applicant Smith & Nephew, Inc.

K number K090955

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GXI 2008-11-10

TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC

Applicant Top Corp.

K number K080771

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GXI 2008-10-14

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN

Applicant Cosman Medical, Inc.

K number K082012

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GXI 2007-07-20

MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

Applicant Smith & Nephew, Inc.

K number K071300

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GXI 2007-07-19

BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE

Applicant Baylis Medical Co., Inc.

K number K071745

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GXI 2007-02-15

TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL

Applicant Top Corp.

K number K062946

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GXI 2007-01-08

TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU

Applicant Baylis Medical Co., Inc.

K number K062937

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GXI 2006-11-21

SMITH & NEPHEW RF CANNULAE

Applicant Smith & Nephew, Inc.

K number K063467

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GXI 2006-08-31

RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED

Applicant PAJUNK GmbH Medizintechnologie

K number K060397

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GXI 2006-05-02

COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA

Applicant Cosman Medical, Inc.

K number K060799

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GXI 2006-04-25

LESIONPOINT RF CANNULA

Applicant Cosman Medical, Inc.

K number K053415

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GXI 2005-11-30

BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6

Applicant Baylis Medical Co., Inc.

K number K053082

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GXI 2005-05-31

STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE

Applicant Stryker Instruments

K number K043442

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GXI 2005-03-17

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;

Applicant Cosman Medical, Inc.

K number K050084

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GXI 2004-10-26

SMK, CX, CXE, RCN

Applicant Technomed Europe

K number K042375

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GXI 2004-09-16

RF INTRODUCTION CANNULA

Applicant Epimed International, Inc.

K number K041021

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GXI 2004-04-01

STRYKER RF ELECTRODES AND CANNULAE

Applicant Stryker Instruments

K number K032406

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GXI 2004-03-16

SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE

Applicant Smith & Nephew, Inc.

K number K034012

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GXI 2003-10-09

NBD DISPOSABLE RF CANNULAE

Applicant New Business Development, LLC

K number K032196

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GXI 2002-09-11

RADIONICS POLE NEEDLES

Applicant Radionics, A Division of Tyco Healthcare Group LP

K number K021942

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GXI 2001-09-06

NEUROTHERM, MODEL JK4

Applicant Eurolink, LLC

K number K011387

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GXI 2000-10-23

BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY

Applicant Baylis Medical Co., Inc.

K number K002389

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GXI 2000-08-17

ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20

Applicant Arthrocare Corp.

K number K001588

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GXI 2000-03-21

NEUROTHERM RF CANNULA

Applicant Rocket Medical Plc

K number K994344

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GXI 2000-03-01

MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA

Applicant Mercury Medical

K number K000073

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GXI 1999-09-21

RADIONICS MICROELECTRODE KIT

Applicant Radionics, Inc.

K number K991399

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GXI 1998-07-17

BMC RF CANNULA

Applicant Baylis Medical Co., Inc.

K number K972846

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GXI 1998-03-16

RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)

Applicant Radionics, Inc.

K number K980430

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GXI 1988-12-27

MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN

Applicant Advanced Surgical Products, Inc.

K number K884347

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GXI 1988-08-17

STORZ DISPOSABLE BIPOLAR PENCILS

Applicant Storz Instrument Co.

K number K882802

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GXI 1988-04-13

DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150

Applicant Advanced Surgical Products, Inc.

K number K880951

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GXI 1988-04-13

DISPOSABLE WET FIELD ERASER

Applicant Advanced Surgical Products, Inc.

K number K880925

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GXI 1988-03-17

THE STORZ BIPOLAR PENCIL AND CORD

Applicant Storz Instrument Co.

K number K880293

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GXI 1987-10-26

SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE

Applicant Radionics, Inc.

K number K870028

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GXI 1980-11-12

VAXIOM FAMILY OF RF LESION PROBES & ELEC

Applicant Progress Mankind Technology

K number K802243

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