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

    PENTAX FD-34A DUODENOFIBERSCOPE

    K Number: K832006 · Decision Aug 1, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    30
    Applicant Total
    67
    Review Days
    39

    Basic Information

    Device Name
    PENTAX FD-34A DUODENOFIBERSCOPE
    K Number
    K832006
    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
    June 23, 1983
    Decision Date
    August 1, 1983
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FDT), ordered by most recent decision date.

    PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Evis Exera III Duodenovideoscope Olympus TJF-Q190V

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PENTAX Medical Video Duedenoscope ED34-i10T2

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pentax Medical Video Duodenoscope ED32-i10

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Evis Exera III Duodenovideoscope Olympus TJF-Q190V

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by PENTAX PRECISION INSTRUMENT CORP.

    K Number Device Name
    K041397 EG-3830UT
    K041395 EG-3630UR
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    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. →