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510(k) Data Aggregation

    K Number
    K982346
    Device Name
    ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    1999-01-29

    (207 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM

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

    The ANGIODYNAMICS ANGIOSTENT Biliary Stent System is indicated for palliative treatment of malignant strictures in the biliary tree.

    Device Description

    Not Found

    AI/ML Overview

    The provided document, a 510(k) premarket notification letter from the FDA for the AngioDynamics AngioStent Biliary Stent System, does not contain the information requested in your prompt regarding acceptance criteria, device performance results, or details of a study proving the device meets acceptance criteria.

    This letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device and can proceed to market, provided certain labeling limitations are met. It discusses regulatory classifications, general controls, and labeling requirements.

    Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance based on this document. The document's purpose is to grant market clearance, not to present a detailed study report.

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