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510(k) Data Aggregation

    K Number
    K220891
    Device Name
    Kahook Dual Blade Glide (KDB Glide)
    Manufacturer
    New World Medical, Inc.
    Date Cleared
    2024-05-17

    (781 days)

    Product Code
    QUQ, OUO
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    QUQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.
    Device Description
    The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.
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