Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060973
    Device Name
    VYCOR SURGICAL ACCESS SYSTEMS
    Manufacturer
    VYCOR MEDICAL LLC
    Date Cleared
    2006-07-26

    (107 days)

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

    VYCOR MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide for access and allow for visualization of the surgical field during brain and spinal surgery.
    Device Description
    The Vycor Medical Surgical Access Systems include a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region. The variety of devices include: - Brain Access System including three models of varying shapes and sizes. - TC model (elliptical diameters 2.1cm or 1.7cm, lengths 3,5,7, or 9 cm) - EC model (3.4 cm diameter, 3,5, 7 cm lengths) - SF model (channel 2.2cm or 2.5cm, length 3,5, or 7 cm) - Spinal Access System - (aperture widths are 2.6 to 5.4 cm, and 3 or 5cm access channel height) Each device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues. The port is transparent to allow direct visualization of the underlying retracted anatomical structures. The retractors are light weight, non-conductive, and are compatible with Lelya positioning clamps to provide fixation and reduce accidental movement. The spinal access device can access the spine for surgical procedures. The spinal access device has three components including the introducer, port, and fixation screws. The fixation screws are used to hold the device in place during the surgery. The fixation screws are temporarily screwed into surrounding bone tissue during the surgical procedure.
    Ask a Question

    Page 1 of 1