BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P980020 · Decision Dec 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    Q 103 NEEDLE MANAGEMENT SYSTEM
    PMA Number
    P980020
    Device Class
    FDA Class 2
    Product Code
    MTV
    Generic Name
    Sharps needle destruction device
    Regulation Number
    880.6210
    Medical Specialty
    General Hospital
    Advisory Committee
    General Hospital
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 21, 2000
    Date Received
    May 26, 1998
    Expedited Review
    N
    Docket Number
    00M-1684

    Advisory Committee Statement

    APPROVAL FOR THE QCARE NEEDLE MANAGEMENT SYSTEM. THIS DEVICE IS A NEEDLE DESTRUCTION DEVICE INTENDED TO BE USED IN A HOME CARE ENVIRONMENT TO SEVER 1/2 INCH HYPODERMIC NEEDLES (GAUGES 28-29) FROM INSULIN SYRINGES AND STORE THEM FOR DISPOSAL.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTV Sharps Needle Destruction Device