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510(k) Data Aggregation

    K Number
    K061690
    Device Name
    SURGICAL HEADLIGHT
    Manufacturer
    GULF MEDICAL FIBEROPTICS
    Date Cleared
    2006-09-15

    (92 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The use for this particular device is to be worn on the surgeons head and to illuminate the body cavity during examinations or surgical procedures. This product is shipped to the end user non-sterile.

    Device Description

    Surgical Headlight

    AI/ML Overview

    This is a 510(k) premarket notification for a Surgical Headlight. The provided document is a letter from the FDA determining substantial equivalence to a legally marketed predicate device. It does not contain information about acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot provide the requested information. The document is solely an administrative approval letter based on equivalence to existing devices, not a performance evaluation.

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