BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ECLIPSE SYSTEM

    K Number: DEN140020 · Decision Feb 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    233

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    Basic Information

    Device Name
    ECLIPSE SYSTEM
    K Number
    DEN140020
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5930
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Pelvalon
    Date Received
    June 24, 2014
    Decision Date
    February 12, 2015
    Product Code
    PJH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Expedited Review
    Y
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PJH Dynamic Rectal Control System

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