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

    ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL

    K Number: K881469 · Decision Sep 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    26
    Applicant Total
    505
    Review Days
    158

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    Basic Information

    Device Name
    ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
    K Number
    K881469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    April 7, 1988
    Decision Date
    September 12, 1988
    Product Code
    FER
    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
    FER Anoscope And Accessories

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