BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SOLOASSIST II

    K Number: K171947 · Decision Sep 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    163
    Applicant Total
    4
    Review Days
    449

    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
    SOLOASSIST II
    K Number
    K171947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aktormed GmbH
    Date Received
    June 29, 2017
    Decision Date
    September 21, 2018
    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 Aktormed GmbH

    K Number Device Name
    K233312 SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
    K232405 ENDOFIX EXO
    K200473 SoloAsisst II, Voice Control