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

    FUJINON ULTRASONIC PROCESSOR

    K Number: K111243 · Decision May 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    30
    Review Days
    13

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    Basic Information

    Device Name
    FUJINON ULTRASONIC PROCESSOR
    K Number
    K111243
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujinon, Inc.
    Date Received
    May 3, 2011
    Decision Date
    May 16, 2011
    Product Code
    FDS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FDS Gastroscope And Accessories, Flexible/Rigid

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    Other Clearances by Fujinon, Inc.

    K Number Device Name
    K120446 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
    K112391 FUJINON COLONOSCOPES
    K102466 FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
    K091773 FUJINON STERILE OVERTUBES
    K090116 FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
    K063316 FUJINON MODEL EG-530N TRANS NASAL INSERTION
    K063847 FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
    K050907 FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
    K042043 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
    K042076 FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
    Search all 30 clearances from Fujinon, Inc. →