BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ultrasonic Gastrovideoscope

    K Number: K231813 · Decision Mar 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    42
    Applicant Total
    25
    Review Days
    261

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    Basic Information

    Device Name
    Ultrasonic Gastrovideoscope
    K Number
    K231813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonoscape Medical Corp.
    Date Received
    June 21, 2023
    Decision Date
    March 8, 2024
    Product Code
    ODG
    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
    ODG Endoscopic Ultrasound System, Gastroenterology-Urology

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