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510(k) Data Aggregation

    K Number
    K971538
    Device Name
    MENTOR GEMINI HEMOSTATIC ERASER
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Date Cleared
    1997-07-14

    (77 days)

    Product Code
    HQO
    Regulation Number
    886.4115
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    k971538
    Why did this record match?
    Device Name :

    MENTOR GEMINI HEMOSTATIC ERASER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.

    Device Description

    The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.

    AI/ML Overview

    This 510(k) summary explicitly states: "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical." This means the submission does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information from the provided text. The device's substantial equivalence was determined based on its similarity in indications, design, and features to a predicate device, not on specific performance data or clinical studies.

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