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510(k) Data Aggregation

    K Number
    K023506
    Device Name
    SURGICAL MEDICAL DEVICE CAUTERY
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG., LTD.
    Date Cleared
    2004-01-13

    (452 days)

    Product Code
    HQP
    Regulation Number
    886.4115
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGICAL MEDICAL DEVICE CAUTERY

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

    The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear. Use for controlling diffuse bleeding and sculpting woven grafts.

    Device Description

    The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Disposable Battery Powered Cautery). It establishes substantial equivalence to a predicate device and provides regulatory information.

    However, this document does not contain any information regarding acceptance criteria, device performance results, study design, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

    Therefore, I cannot extract the information required to answer your request.

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