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

    SpyGlass DS Direct Visualization System

    K Number: K142922 · Decision Jan 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    38
    Applicant Total
    26
    Review Days
    100

    Basic Information

    Device Name
    SpyGlass DS Direct Visualization System
    K Number
    K142922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON SCIENTIFIC CORPORATION
    Date Received
    October 8, 2014
    Decision Date
    January 16, 2015
    Product Code
    FBN
    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
    FBN Choledochoscope And Accessories, Flexible/Rigid

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