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

    SmartSurgN Visualization System

    K Number: K242163 · Decision Apr 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    635

    Basic Information

    Device Name
    SmartSurgN Visualization System
    K Number
    K242163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SmartsurgN, Inc.
    Date Received
    July 24, 2024
    Decision Date
    April 20, 2026
    Product Code
    OWN
    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
    OWN Confocal Optical Imaging

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    Other Clearances by SmartsurgN, Inc.

    K Number Device Name
    K242772 AirSurgN Insufflator (10030/AirSurgN)