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

    Sharps Needle Destruction Device

    PMA: P980015 · Decision Aug 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    SHARPX
    PMA Number
    P980015
    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
    August 6, 1998
    Date Received
    May 8, 1998
    Expedited Review
    N
    Docket Number
    98M-0679

    Advisory Committee Statement

    Approval for the Sharpx(TM) Needle Destruction Unit. The device is indicated for the destruction of 19 to 27 gauge hypodermic needles up to two inches in length. The unit is for use by healthcare professionals in out-patient and in-patient treatment settings and clinical laboratoreis.

    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