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

    Senhance Surgical System

    K Number: K211325 · Decision Jul 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    163
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    Senhance Surgical System
    K Number
    K211325
    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, Inc.
    Date Received
    April 30, 2021
    Decision Date
    July 27, 2021
    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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    Other Clearances by Asensus Surgical, Inc.

    K Number Device Name
    K233866 Senhance Surgical System
    K223095 Senhance Surgical System
    K220889 Senhance Surgical System
    K212054 Senhance Surgical System