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

    FLEXSCOPE

    K Number: K961536 · Decision Sep 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    14
    Review Days
    149

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    Basic Information

    Device Name
    FLEXSCOPE
    K Number
    K961536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Matrix Medica, Inc.
    Date Received
    April 22, 1996
    Decision Date
    September 18, 1996
    Product Code
    GDB
    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
    GDB Endoscope, Fiber Optic

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