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

    CereLink ICP Monitor

    K Number: K210993 · Decision Apr 30, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    CereLink ICP Monitor
    K Number
    K210993
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Production Corporation
    Date Received
    April 2, 2021
    Decision Date
    April 30, 2021
    Product Code
    GWM
    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
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Integra Lifesciences Production Corporation

    K Number Device Name
    K243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
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    K232890 CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
    K233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
    K233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
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    K221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves