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

    SoloAsisst II, Voice Control

    K Number: K200473 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    163
    Applicant Total
    4
    Review Days
    300

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    Basic Information

    Device Name
    SoloAsisst II, Voice Control
    K Number
    K200473
    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
    February 26, 2020
    Decision Date
    December 22, 2020
    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 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
    K171947 SOLOASSIST II