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

    Senhance Surgical System

    K Number: K223095 · Decision Mar 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    163
    Applicant Total
    5
    Review Days
    167

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Senhance Surgical System
    K Number
    K223095
    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
    September 30, 2022
    Decision Date
    March 16, 2023
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NAY), ordered by most recent decision date.

    da Vinci Firefly Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Senhance Ultrasonic System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    da Vinci Force Feedback Instruments

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    da Vinci Surgical System (IS5000)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    da Vinci SP Surgical System (SP1098)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Asensus Surgical, Inc.

    K Number Device Name
    K233866 Senhance Surgical System
    K220889 Senhance Surgical System
    K212054 Senhance Surgical System
    K211325 Senhance Surgical System