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510(k) Data Aggregation

    K Number
    K210615
    Date Cleared
    2022-05-13

    (438 days)

    Product Code
    Regulation Number
    882.4800
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thompson Brain Retractor Table Mounted and Skull Clamp Mounted Systems are indicated for self-retaining retraction of soft tissue during neurological procedures to provide surgical access and exposure. The Thompson Brain Retractor Systems also allow attachment for applicable accessories and function as a hand-rest for the surgeon.

    Device Description

    Thompson Surgical Instruments Brain Retractor is a reusable manual instrument made from stainless steel and aluminum, as indicated. It is composed of materials that can be reused with steam sterilization methods. It is provided to the customer non-sterile. The Thompson Brain Retractor is a retractor system used to create adequate exposure of the cranial region to assist surgeons in accessing areas for surgery. The system is comprised of a stainless-steel frame with 1/2-inch diameter frame components, which create a plane over the access point in the skull of the patient. The system uses stainless steel flexible arms that are attached to the frame to hold blades (stainless steel), which ultimately retract the tissue for the needed exposure. The frame also acts as a rest for the surgeons' wrists/hands during the procedure, as well as an attachment point for various accessories to aid the surgeon (ex: pattie tray).

    The system uses clamps, cam actuation, and screws to construct and support the frame. The flexible arms are attached to the frame via screw down mechanism and the flexible arms are tightened into a semi-rigid state also using a screw mechanism, very similar to the function of all the predicate devices.

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