BEUDAMED
    Product Code: GXI FDA class 2 21 CFR 882.4725

    Probe, Radiofrequency Lesion

    Neurology

    The Radiofrequency Lesion Probe is a neurosurgical electrode used in conjunction with a radiofrequency generator to create precise thermal lesions in neural tissue for pain management or treatment of neurological conditions such as trigeminal neuralgia and movement disorders. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXI under regulation 21 CFR 882.4725 in the Neurology medical specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    63
    FEI Numbers
    85
    Registration Numbers
    85
    Unique Applicants
    36
    Years Active
    45

    Basic Information

    Product Code
    GXI
    Device Class
    FDA class 2
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 63 510(k) clearances via K numbers.

    K Number Device Name
    K242841 Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
    K250213 OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
    K241367 RF Cannula
    K222281 Intracept Intraosseous Nerve Ablation System
    K213836 Intracept Intraosseous Nerve Ablation System
    K203066 COOLIEF Cooled Radiofrequency Kit Advanced
    K190259 Vesta RF Cannula
    K191293 LCCS VC-S RF Cannula
    K190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
    K190256 Rulo Radiofrequency Lesion Probe
    K183177 Nitinol Thermocouple (TCN) Electrode
    K180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
    K170827 INTRACEPT Intraosseous Nerve Ablation System
    K170708 OWL RF INSULATED CANNULAE
    K163461 Coolief* Cooled RF Probe
    K163236 COOLIEF Cooled Radiofrequency Kit
    K152642 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
    K153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
    K150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
    K141586 OWL CANNULAE
    K123178 STRYKER VENOM ELECTRODES AND CANNULAE
    K121773 NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
    K112231 LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
    K102566 OWL CANNULAE
    K110593 OWL RF PROBES
    K101372 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
    K090608 MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
    K092337 PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
    K090955 SMITH & NEPHEW RF CANNULATE
    K080771 TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
    K082012 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
    K071300 MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
    K071745 BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
    K062946 TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
    K062937 TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
    K063467 SMITH & NEPHEW RF CANNULAE
    K060397 RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
    K060799 COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
    K053415 LESIONPOINT RF CANNULA
    K053082 BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
    K043442 STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
    K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
    K042375 SMK, CX, CXE, RCN
    K041021 RF INTRODUCTION CANNULA
    K032406 STRYKER RF ELECTRODES AND CANNULAE
    K034012 SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
    K032196 NBD DISPOSABLE RF CANNULAE
    K021942 RADIONICS POLE NEEDLES
    K011387 NEUROTHERM, MODEL JK4
    K002389 BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
    K001588 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
    K994344 NEUROTHERM RF CANNULA
    K000073 MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
    K991399 RADIONICS MICROELECTRODE KIT
    K972846 BMC RF CANNULA
    K980430 RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)
    K884347 MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
    K882802 STORZ DISPOSABLE BIPOLAR PENCILS
    K880951 DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
    K880925 DISPOSABLE WET FIELD ERASER
    K880293 THE STORZ BIPOLAR PENCIL AND CORD
    K870028 SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE
    K802243 VAXIOM FAMILY OF RF LESION PROBES & ELEC

    FEI Numbers

    This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.