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

    Sharps Needle Destruction Device

    PMA: P120018 · Decision Feb 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    SHARPS TERMINATOR
    PMA Number
    P120018
    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
    February 17, 2016
    Date Received
    October 23, 2012
    Expedited Review
    N
    Docket Number
    16M-0806

    Advisory Committee Statement

    Approval for the Sharps Terminator. This device is indicated for use by individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm). The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories.

    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