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

    ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES

    K Number: K993103 · Decision Dec 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    17
    Applicant Total
    142
    Review Days
    85

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    Basic Information

    Device Name
    ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES
    K Number
    K993103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Richard Wolf Medical Instruments Corp.
    Date Received
    September 16, 1999
    Decision Date
    December 10, 1999
    Product Code
    GCM
    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
    GCM Endoscope, Rigid

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