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

    Senhance Ultrasonic System

    K Number: K254192 · Decision May 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    163
    Applicant Total
    1
    Review Days
    140

    Basic Information

    Device Name
    Senhance Ultrasonic System
    K Number
    K254192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asensus Surgical
    Date Received
    December 23, 2025
    Decision Date
    May 12, 2026
    Product Code
    NAY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NAY System, Surgical, Computer Controlled Instrument

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