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

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    K Number: K091816 · Decision Jul 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    55
    Applicant Total
    193
    Review Days
    13

    Basic Information

    Device Name
    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    K Number
    K091816
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    June 18, 2009
    Decision Date
    July 1, 2009
    Product Code
    ESW
    Advisory Committee
    General, Plastic Surgery
    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
    ESW Prosthesis, Esophageal

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