BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    InstaFAN

    K Number: K251542 · Decision Jul 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    59

    Basic Information

    Device Name
    InstaFAN
    K Number
    K251542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onepass Medical , Ltd.
    Date Received
    May 20, 2025
    Decision Date
    July 18, 2025
    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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