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510(k) Data Aggregation

    K Number
    K202072
    Device Name
    MindsEye Expandable Port
    Manufacturer
    Minnetronix Neuro, INC.
    Date Cleared
    2020-08-26

    (30 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Minnetronix Neuro, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery. The device is indicated for use in surgery during which subcortical access is required.
    Device Description
    The MindsEye Expandable Port is a single use, minimally invasive intracranial medical device designed to provide access and allow visualization to the surgical field while retracting subcortical soft tissues during neurological cranial surgery. Its design allows the user to place the port while collapsed in its minimal form for atraumatic access to the subcortical space. After placement, the port can be expanded radially to create a working channel to the target surgical location. The user is able to expand the port to the desired working channel diameter appropriate for the surgical plan then collapse the port upon surgical completion for safe removal. The working channel diameter may be adjusted as needed by the user throughout surgery. The MindsEye device is expected to be used in conjunction with other standard, commercially available intracranial medical devices, such as an aspirator, micro/endo/exoscope, irrigation, electrosurgical systems/tools and/or hemostatic agents. In addition, MindsEye is compatible with existing optical navigation systems for accurate target acquisition and may be attached to other commercial retraction systems according to user preference. The MindsEye device is made of biocompatible, medical grade materials (metals and polymers) with no software or electrical components. The MindsEye device and its components are provided sterile and not reusable. MindsEye is comprised of the following components and is available in three lengths (Table 1). - Port with attached Sheath - Obturator and Guide - Optional Support System consisting of support clips, post, and legs
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