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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: GWG FDA class 2

    Endoscope, Neurological

    Neurology

    View full classification →

    The Endoscope, Neurological is a rigid or flexible optical instrument used to visually examine structures within the neurological system, such as the ventricles of the brain, enabling minimally invasive diagnostic and therapeutic procedures in neurosurgery. It is an FDA Class 2 device, requiring 510(k) premarket clearance; if the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission. The product code is GWG, regulated under 21 CFR 882.1480 in the Neurology specialty. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HJY VisualNext 3D Endoscopic Vision System
    AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
    cCeLL - In vivo
    Digital ClarusScope System, Digital NeuroPEN System
    Aurora Surgiscope System
    Neuroblade System
    QEVO System
    HJY VisualNext Endoscopic Vision System
    1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
    ClearPath Disposable Introducer
    Clarus Peel-Away Introducer Sheath
    Axonpen, Axonmonitor, Axonbox, Tablet
    Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
    Aurora Surgiscope System
    Artemis Eye System
    Aurora Surgiscope System
    MR Compatible Aspiration Kit
    CONVIVO
    Cellvizio 100 Series Systems with Confocal Miniprobes
    KARL STORZ ICG Imaging System
    QEVO System with KINEVO 900
    Artemis Neuro Evacuation Device
    KARL STORZ ShuntScope
    TIPCAM 1S 3D System
    KARL STORZ Flexible Video-Neuro-Endoscope System
    Apollo System
    MINOP Disposable Introducer 26F
    APOLLO SYSTEM
    VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
    VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
    KSEA CLEARVISION II, MODEL 40334120
    MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
    ASSISTO ARM SYSTEMS
    OLYMPUS ENDOARM
    NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES
    ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
    OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
    MSS-28CS-301/701 NEEDLESCOPE
    KSEA NEUROENDOSCOPES AND ACCESSORIES
    PAEDISCOPE, MODEL # P010A AND PF011A
    MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,,
    MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
    MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005
    KSEA MINIATURE NEUROENDOSCOPE
    KSEA NEURO-FIBERSCOPE
    NAVIGUS PEEL AWAY INTRODUCER
    KSEA BIPOLAR COAGULATING ELECTRODES
    MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
    DCI ENDOSCOPE
    MITAKA POINT SETTER

    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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