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510(k) Data Aggregation

    K Number
    K072684
    Device Name
    MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
    Manufacturer
    MONDEAL NORTH AMERICA, INC
    Date Cleared
    2008-01-04

    (105 days)

    Product Code
    OCZ, SUB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONDEAL NORTH AMERICA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament. Indications for use: The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following: Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment. Endoscopic Plantar Fasciotomy (EPF) – as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment. Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.
    Device Description
    The Mondeal Endoscopic Tissue Recession and Release System is a minimally invasive device for gaining exposure to perform Gastrocnemius Tenotomy, Plantar Fasciitis Recession, and Carpal Tunnel Release. The system is comprised of the instruments required to perform the above mentioned maladies in conjunction with commercially available endoscopes. The instruments include an obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and knife(s). The system requires bi-portal incisions to pass the cannula from one side of the intended recession/resection to the other, allowing the knife to perform a complete and verified recession/release. The cannula locking mechanism aids the surgeon in ensuring the cannula does not move while performing the procedure. The knife is offered in two different designs. One design is for forward cutting (away from the surgeon), the other is for reverse cutting (towards the surgeon). The benefits of each design are dependent upon which procedure the device is used for and surgeon preference.
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