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

    Eclipse System

    K Number: K150558 · Decision Nov 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    253

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    Basic Information

    Device Name
    Eclipse System
    K Number
    K150558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5930
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pelvalon, Inc.
    Date Received
    March 4, 2015
    Decision Date
    November 12, 2015
    Product Code
    PJH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PJH), ordered by most recent decision date.

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