BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

    K Number: K192945 · Decision Nov 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    9
    Review Days
    40

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    Basic Information

    Device Name
    7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
    K Number
    K192945
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    7D Surgical, Inc.
    Date Received
    October 18, 2019
    Decision Date
    November 27, 2019
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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