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

    PENTAX UPPER G.I. FIBERSCOPE, #FG-34

    K Number: K810007 · Decision Jan 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    67
    Review Days
    10

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    Basic Information

    Device Name
    PENTAX UPPER G.I. FIBERSCOPE, #FG-34
    K Number
    K810007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    January 5, 1981
    Decision Date
    January 15, 1981
    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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    Other Clearances by Pentax Precision Instrument Corp.

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    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    Search all 67 clearances from Pentax Precision Instrument Corp. →