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

    MAEDA NEW NEEDLE DISPOSABLE

    K Number: K000581 · Decision Feb 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    2
    Review Days
    367

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    Basic Information

    Device Name
    MAEDA NEW NEEDLE DISPOSABLE
    K Number
    K000581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maeda Toyokichi Shoten
    Date Received
    February 22, 2000
    Decision Date
    February 23, 2001
    Product Code
    MQX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQX Needle, Acupuncture, Single Use

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    Other Clearances by Maeda Toyokichi Shoten

    K Number Device Name
    K021904 MAEDA SILVER ACUPUNCTURE NEEDLE