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510(k) Data Aggregation

    K Number
    K113697
    Device Name
    EIGR SURGICAL ILLUMINATION SYSTEM
    Manufacturer
    INVUITY, INC.
    Date Cleared
    2012-02-10

    (56 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EIGR SURGICAL ILLUMINATION SYSTEM

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

    The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Invuity® Eigr™ Surgical Illumination System. It indicates that the device is substantially equivalent to a predicate device and is intended to provide surgical site illumination.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

    Therefore, it is not possible to answer the user's request based on the provided text. The document is solely a regulatory approval letter and does not include the technical study details requested.

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