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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: GXD FDA class 2

    Generator, Lesion, Radiofrequency

    Neurology

    View full classification →

    The Radiofrequency Lesion Generator is a neurosurgical device used to create controlled thermal lesions in neural tissue, typically for pain management or the treatment of movement disorders by interrupting aberrant nerve pathways. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is GXD under regulation 21 CFR 882.4400 in the Neurology specialty. It is eligible for third-party review under the 510(k) program.

    510(k) Clearances

    37 matches
    K Number
    Device Name
    GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
    COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
    Racz Neurostat RF Generator
    OneRF Ablation System
    APEX 6
    Abbott Medical Grounding Pad, model RF-DGP-IS
    IonicRF Generator
    Coolief Radiofrequency Generator (CRG) System
    Polaris RF Ablation System
    Relievant Medsystems RF Generator
    MultiGen™ 2 RF Generator System
    ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
    NT 2000 LESIONING GENERATOR
    OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
    COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
    MODIFICATION TO GFX NERVE ABLATION SYSTEM
    STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
    GFX NERVE ABLATION SYSTEM
    STOCKERT NEURO N50, MODEL12267
    STRYKER INTRADISCAL RF GENERATOR
    OWL URF-3AP
    NT-1000
    PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
    STRYKER INTERVENTIONAL PAIN RF GENERATOR
    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
    BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
    OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
    BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
    NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
    RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
    RFG-3C PLUS
    RFG-3CF
    RADIONICS SLUIJTER-MEHTA CANNULA
    LEKSELL NEURO GENERATOR AND ACCESSORIES
    MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
    MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR
    NEURO N 50 LESION GENERATOR

    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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