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

    Hugo™ RAS System

    K Number: K250725 · Decision Dec 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    2
    Applicant Total
    89
    Review Days
    268

    Basic Information

    Device Name
    Hugo™ RAS System
    K Number
    K250725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4964
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, LLC
    Date Received
    March 10, 2025
    Decision Date
    December 3, 2025
    Product Code
    SCV
    Advisory Committee
    General, Plastic Surgery
    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
    SCV Modular Electromechanical Surgical System

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