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

    GASPARAITIS ESOPHAGRAM CATHETER SET

    K Number: K911897 · Decision Jul 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    56
    Review Days
    86

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    Basic Information

    Device Name
    GASPARAITIS ESOPHAGRAM CATHETER SET
    K Number
    K911897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E-Z-Em, Inc.
    Date Received
    April 29, 1991
    Decision Date
    July 24, 1991
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by E-Z-Em, Inc.

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