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

    EKOS ultrasound EVD Device, EVD Control Unit

    K Number: K172035 · Decision Mar 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    6
    Review Days
    262

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    Basic Information

    Device Name
    EKOS ultrasound EVD Device, EVD Control Unit
    K Number
    K172035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Btg International, Inc.
    Date Received
    July 5, 2017
    Decision Date
    March 24, 2018
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Btg International, Inc.

    K Number Device Name
    K191119 EkoSonic Endovascular Device
    K183361 EkoSonic Endovascular Device with Control Unit 4.0
    K182324 EkoSonic Endovascular System
    K162771 EkoSonic Endovascular System with Control Unit 4.0
    K140151 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT