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

    GALILEO ENDOSCOPES

    K Number: K934649 · Decision Oct 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    379

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    Basic Information

    Device Name
    GALILEO ENDOSCOPES
    K Number
    K934649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Galileo Electro-Optics Corp.
    Date Received
    September 29, 1993
    Decision Date
    October 13, 1994
    Product Code
    FBO
    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
    FBO Cystourethroscope

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    Other Clearances by Galileo Electro-Optics Corp.

    K Number Device Name
    K981928 GALILEO DISPOSABLE ENDOSCOPES
    K962256 GALILEO HYSTEROSCOPES AND LAPAROSCOPES
    K962116 GALILEO ENDOSCOPES
    K934707 GALILEO ARTHROSCOPES
    K936280 GALILEO ARTHROSCOPES
    K936279 GALILEO ENDOSCOPES