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

    ESOPHAGEAL OVERTUBE

    K Number: K890629 · Decision May 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    5
    Review Days
    110

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    Basic Information

    Device Name
    ESOPHAGEAL OVERTUBE
    K Number
    K890629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gastrotech, Inc.
    Date Received
    February 10, 1989
    Decision Date
    May 31, 1989
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Gastrotech, Inc.

    K Number Device Name
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