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

    FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE

    K Number: K892000 · Decision Apr 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    23
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE
    K Number
    K892000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Schott Fiber Optics, Inc.
    Date Received
    March 28, 1989
    Decision Date
    April 25, 1989
    Product Code
    FAM
    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
    FAM Sigmoidoscope And Accessories, Flexible/Rigid

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    Other Clearances by Schott Fiber Optics, Inc.

    K Number Device Name
    K892390 FLEXIBLE IMMERSIBLE HYSTEROSCOPE