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

    TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.

    K Number: K864960 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    54
    Review Days
    50

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    Basic Information

    Device Name
    TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
    K Number
    K864960
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cooper Lasersonics, Inc.
    Date Received
    December 22, 1986
    Decision Date
    February 10, 1987
    Product Code
    GCQ
    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
    GCQ Endoscope, Flexible

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