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510(k) Data Aggregation

    K Number
    K183470
    Device Name
    Precision Ideal Eyes Arthroscopes
    Manufacturer
    Stryker
    Date Cleared
    2019-01-07

    (24 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K202659
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Precision Ideal Eyes Arthroscopes". This letter primarily deals with the administrative aspects of the FDA's substantial equivalence determination and regulatory compliance requirements.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

    Therefore, I cannot fulfill your request for this specific information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, a 510(k) submission summary, or a clinical study report for the device.

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