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

    Sharps Needle Destruction Device

    PMA: P010040 · Decision Mar 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE
    PMA Number
    P010040
    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
    March 15, 2002
    Date Received
    August 1, 2001
    Expedited Review
    N
    Docket Number
    02M-0118

    Advisory Committee Statement

    APPROVAL FOR THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE. THE DEVICE IS INDICATED FOR INSULIN NEEDLE DESTRUCTION FOR HOME USE.

    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