Atlas FDA

GXI

66 FDA 510(k) clearances · Product code

101 daysmedian time to decision
255 days90th percentile
66clearances measured

FDA profile

Official device name
Probe, Radiofrequency Lesion
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4725
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 30 · 2022: 46 · 2023: 35 · 2024: 45 · 2025: 98 · 2026: 71
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Disposable Radiofrequency Cannula (K253907)ABBOTT MEDICAL2026-04-16
STAR RF Ablation System (K251802)Merit Medical Systems, Inc.2026-02-13
OneRF Trigeminal Nerve Radiofrequency Probes (K251243)Neuroone Medical Technologies Corp.2025-08-15
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) (K242841)ABBOTT MEDICAL2025-05-27
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) (K250213)Stryker Instruments2025-05-15
RF Cannula (K241367)Shanghai Samedical & Plastic Instruments Co., Ltd.2025-01-23
Intracept Intraosseous Nerve Ablation System (K222281)Relievant Medsystems, Inc.2022-10-26
Intracept Intraosseous Nerve Ablation System (K213836)Relievant Medsystems, Inc.2022-03-11
COOLIEF Cooled Radiofrequency Kit Advanced (K203066)Avanos Medical, Inc.2020-12-22
Vesta RF Cannula (K190259)Biomerics2020-02-07
LCCS VC-S RF Cannula (K191293)Lccs Products Limited2020-01-24
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504)Relievant Medsystems2019-05-03
Nitinol Thermocouple (TCN) Electrode (K183177)Boston Scientific Corporation2019-03-08
Rulo Radiofrequency Lesion Probe (K190256)Epimed International, Inc.2019-03-08
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (K180369)Relievant Medsystems2018-09-14
INTRACEPT Intraosseous Nerve Ablation System (K170827)Relievant Medsystems2017-08-09
OWL RF INSULATED CANNULAE (K170708)Diros Technology, Inc.2017-06-27
Coolief* Cooled RF Probe (K163461)Halyard Health, Inc.2017-04-13
COOLIEF Cooled Radiofrequency Kit (K163236)Halyard Health, Inc.2016-12-16
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode (K152642)Lccs Products Limited2016-08-26
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (K153272)Relievant Medsystems2016-07-09
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH (K150371)Diros Technology, Inc.2015-07-30
OWL CANNULAE (K141586)Diros Technology, Inc.2014-12-30
STRYKER VENOM ELECTRODES AND CANNULAE (K123178)Stryker Instruments, Instruments Div.2013-03-28
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE (K121773)Biomerics2012-09-21
LCCS INSULATED SPINAL NEEDLE (RF CANNULA) (K112231)Lccs Products Limited2011-08-19
OWL CANNULAE (K102566)Diros Technology, Inc.2011-06-03
OWL RF PROBES (K110593)Diros Technology, Inc.2011-05-05
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (K101372)Baylis Medical Co., Inc.2010-08-10
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) (K090608)Minta Medical Limited2010-06-14
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (K092337)Baylis Medical Co., Inc.2009-10-16
SMITH & NEPHEW RF CANNULATE (K090955)Smith & Nephew, Inc.2009-07-16
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC (K080771)Top Corp.2008-11-10
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN (K082012)Cosman Medical, Inc.2008-10-14
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K071300)Smith & Nephew, Inc.2007-07-20
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE (K071745)Baylis Medical Co., Inc.2007-07-19
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL (K062946)Top Corp.2007-02-15
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.2007-01-08
SMITH & NEPHEW RF CANNULAE (K063467)Smith & Nephew, Inc.2006-11-21
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED (K060397)PAJUNK GmbH Medizintechnologie2006-08-31
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA (K060799)Cosman Medical, Inc.2006-05-02
LESIONPOINT RF CANNULA (K053415)Cosman Medical, Inc.2006-04-25
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 (K053082)Baylis Medical Co., Inc.2005-11-30
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE (K043442)Stryker Instruments2005-05-31
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; (K050084)Cosman Medical, Inc.2005-03-17
SMK, CX, CXE, RCN (K042375)Technomed Europe2004-10-26
RF INTRODUCTION CANNULA (K041021)Epimed International, Inc.2004-09-16
STRYKER RF ELECTRODES AND CANNULAE (K032406)Stryker Instruments2004-04-01
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K034012)Smith & Nephew, Inc.2004-03-16
NBD DISPOSABLE RF CANNULAE (K032196)New Business Development, LLC2003-10-09
RADIONICS POLE NEEDLES (K021942)Radionics, A Division of Tyco Healthcare Group LP2002-09-11
NEUROTHERM, MODEL JK4 (K011387)Eurolink, LLC2001-09-06
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY (K002389)Baylis Medical Co., Inc.2000-10-23
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 (K001588)Arthrocare Corp.2000-08-17
NEUROTHERM RF CANNULA (K994344)Rocket Medical Plc2000-03-21
MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (K000073)Mercury Medical2000-03-01
RADIONICS MICROELECTRODE KIT (K991399)Radionics, Inc.1999-09-21
BMC RF CANNULA (K972846)Baylis Medical Co., Inc.1998-07-17
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) (K980430)Radionics, Inc.1998-03-16
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (K884347)Advanced Surgical Products, Inc.1988-12-27
STORZ DISPOSABLE BIPOLAR PENCILS (K882802)Storz Instrument Co.1988-08-17
DISPOSABLE WET FIELD ERASER (K880925)Advanced Surgical Products, Inc.1988-04-13
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150 (K880951)Advanced Surgical Products, Inc.1988-04-13
THE STORZ BIPOLAR PENCIL AND CORD (K880293)Storz Instrument Co.1988-03-17
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE (K870028)Radionics, Inc.1987-10-26
VAXIOM FAMILY OF RF LESION PROBES & ELEC (K802243)Progress Mankind Technology1980-11-12

Track GXI automatically

Every clearance here is in the API, with alerts when new ones post.