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

    ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8

    K Number: K031347 · Decision May 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    42
    Applicant Total
    22
    Review Days
    10

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
    K Number
    K031347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical Co., Ltd.
    Date Received
    April 29, 2003
    Decision Date
    May 9, 2003
    Product Code
    ODG
    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
    ODG Endoscopic Ultrasound System, Gastroenterology-Urology

    Similar 510(k) Clearances

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

    RIVOS™ EUS Access Device (M00553900)

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

    EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

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

    InstaFAN

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

    Ultrasonic Gastrovideoscope

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

    EndoSound Vision System; EVS

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

    Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

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

    Other Clearances by Olympus Optical Co., Ltd.

    K Number Device Name
    K033225 EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
    K031305 OLYMPUS ULTRASONIC SURGICAL SYSTEM
    K031648 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
    K032092 OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
    K024138 HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
    K021852 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
    K022445 VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
    K024033 XTJF-160AF DUODENOVIDEOSCOPE
    K023280 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
    K013759 MSS-28CS-301/701 NEEDLESCOPE
    Search all 22 clearances from Olympus Optical Co., Ltd. →