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

    FG-36UX, FIBER ULTRASOUND GASTROSCOPE

    K Number: K010740 · Decision Apr 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    42
    Applicant Total
    67
    Review Days
    35

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    Basic Information

    Device Name
    FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    K Number
    K010740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    March 13, 2001
    Decision Date
    April 17, 2001
    Product Code
    ODG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ODG Endoscopic Ultrasound System, Gastroenterology-Urology

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    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041395 EG-3630UR
    K041397 EG-3830UT
    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
    K964815 AP-4000, AIR PULSE SENSORY STIMULATOR
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