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510(k) Data Aggregation

    K Number
    K253581

    Validate with FDA (Live)

    Device Name
    Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
    Manufacturer
    Technomed Europe
    Date Cleared
    2026-03-15

    (118 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Type
    Traditional
    Panel
    Neurology
    Age Range
    All
    Reference & Predicate Devices
    K062437,K130136,K990015
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K062437, K130136

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable Concentric Needle Electrodes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyography (EMG) and nerve potential signal.

    Device Description

    The Disposable Concentric Needle Electrode (DCNE) is a recording electrode used for recording of bio-electric, electromyography (EMG) or electroencephalography (EEG) signals in patients undergoing clinical neurophysiological testing. It is inserted into muscle tissue of patient, acting as an interface between the EMG equipment and the patient. It is connected to the EMG cable (not in this submission), which is connected to the EMG equipment to detect bio-electric signals distally.
    The subject devices are invasive, single-use and supplied sterile. It is used by healthcare professionals, specifically trained and certified in electrophysiology and recording/monitoring techniques.
    The subject devices consist of 6 variants. The differences between the variants are the diameter, length of the needle and the color of the handle.

    AI/ML Overview

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