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510(k) Data Aggregation

    K Number
    K023758
    Device Name
    BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-09-17

    (313 days)

    Product Code
    OKS
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) substantial equivalence letter for the Becker Transnasal Lacrimal Stent. It does not contain information about acceptance criteria or specific study details proving device performance. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.

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