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510(k) Data Aggregation

    K Number
    K112522
    Device Name
    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    Manufacturer
    FLEXIBLE STENTING SOLUTIONS, INC.
    Date Cleared
    2011-12-30

    (121 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K202685,K072782
    Why did this record match?
    Reference Devices :

    K202685, K072782

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

    The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the FlexStent® Biliary Self Expanding Stent System. It approves the device as substantially equivalent to legally marketed predicate devices for the palliation of malignant strictures in the biliary tree.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter is an approval based on a substantial equivalence determination, not a detailed report of clinical study results.

    Therefore, I cannot fulfill your request for the specific information laid out in your prompt based on the provided text. The document confirms the regulatory approval for marketing, but it does not detail the technical performance and study design data that would typically be found in a clinical study report or a more comprehensive FDA submission summary.

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