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

    Sharps Needle Destruction Device

    PMA: P010065 · Decision Mar 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    NEEDLE ZAP (R)
    PMA Number
    P010065
    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 14, 2003
    Date Received
    December 18, 2001
    Expedited Review
    N
    Docket Number
    03M-0115

    Advisory Committee Statement

    APPROVAL FOR THE NEEDLEZAP. THE DEVICE IS A PORTABLE NEEDLE DESTRUCTION DEVICE THAT IS INDICATED FOR USE BY HEALTH CARE PROFESSIONALS TO DESTROY PREVIOUSLY USED ALUMINUM AND STAINLESS STEEL NEEDLES (GAUGES 16 - 30,3/4- 2 INCHES IN LENGTH) ATTACHED TO SYRINGES. THE NEEDLEZAP PRODUCT IS INTENDED FOR USE IN HEALTH CARE FACILITIES AND TREATMENT 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