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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GXI FDA class 2

    Probe, Radiofrequency Lesion

    Neurology

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
    OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
    RF Cannula
    Intracept Intraosseous Nerve Ablation System
    Intracept Intraosseous Nerve Ablation System
    COOLIEF Cooled Radiofrequency Kit Advanced
    Vesta RF Cannula
    LCCS VC-S RF Cannula
    Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
    Rulo Radiofrequency Lesion Probe
    Nitinol Thermocouple (TCN) Electrode
    Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
    INTRACEPT Intraosseous Nerve Ablation System
    OWL RF INSULATED CANNULAE
    Coolief* Cooled RF Probe
    COOLIEF Cooled Radiofrequency Kit
    LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
    INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
    Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
    OWL CANNULAE
    STRYKER VENOM ELECTRODES AND CANNULAE
    NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
    LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
    OWL CANNULAE
    OWL RF PROBES
    DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
    MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
    PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
    SMITH & NEPHEW RF CANNULATE
    TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
    COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
    MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
    BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
    TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
    TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
    SMITH & NEPHEW RF CANNULAE
    RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
    COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
    LESIONPOINT RF CANNULA
    BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
    STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
    COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;
    SMK, CX, CXE, RCN
    RF INTRODUCTION CANNULA
    STRYKER RF ELECTRODES AND CANNULAE
    SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
    NBD DISPOSABLE RF CANNULAE
    RADIONICS POLE NEEDLES
    NEUROTHERM, MODEL JK4
    BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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