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

    Sharps Needle Destruction Device

    PMA: P970036 · Decision Sep 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    NIC 1800 NEEDLE DISPOSAL SYSTEM
    PMA Number
    P970036
    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
    September 26, 1997
    Date Received
    August 8, 1997
    Expedited Review
    N
    Docket Number
    98M-0039

    Advisory Committee Statement

    Approval for the NiC1800 Needle Disposal System. This device is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19 gauge through 28 gauge, up to 2 inces in length) in patient treatment and clinical laboratory settings.

    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