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

    Sharps Needle Destruction Device

    PMA: P960044 · Decision Mar 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    NEEDLE-EASE TM 2501
    PMA Number
    P960044
    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 6, 1997
    Date Received
    December 6, 1996
    Expedited Review
    N
    Docket Number
    97M-0186

    Advisory Committee Statement

    APPROVAL FOR THE NEEDLE-EASE(TM) 2501. THIS DEVICE IS A SHARPS NEEDLE DESTRUCTION DEVICE THAT IS INTENDED FOR HOME USE BY DIABETICS TO REDUCE THE INCIDENCE OF NEEDLESTICKS BY THE INCINERATION OF 28-30 GAUGE NEEDLES, 29 AND 30 GAUGE DIABETIC "PEN TIPS" AND 23-26 GAUGE DIABETIC LANCETS.

    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