BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RE-USABLE CONCENTRIC NEEDLE

    K Number: K953887 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    21
    Review Days
    75

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RE-USABLE CONCENTRIC NEEDLE
    K Number
    K953887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chalgren Enterprises, Inc.
    Date Received
    August 17, 1995
    Decision Date
    October 31, 1995
    Product Code
    IKT
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKT Electrode, Needle, Diagnostic Electromyograph

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IKT), ordered by most recent decision date.

    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)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Allergan Botox Needle Electrode

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Myoject Luer Lock Needle Electrode

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EMG RECORDING ELECTRODE ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Chalgren Enterprises, Inc.

    K Number Device Name
    K982950 FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
    K960591 RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
    K955335 DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
    K953356 EMG RECORDING RING ELECTRODE
    K953354 EMG DISC RECORDING ELECTRODE
    K953361 EMG DISC RECORDING ELECTRODE
    K952690 EMG DISC RECORDING ELECTRODE WITH PIN
    K952908 EMG DISC RECORDING ELECTRODE WITH PIN
    K953886 RE-USABLE MONOPOLAR NEEDLE
    K953219 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN
    Search all 21 clearances from Chalgren Enterprises, Inc. →