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510(k) Data Aggregation

    K Number
    K993651
    Device Name
    O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
    Manufacturer
    SC HENNIG ENTERPRISES EUROPE SRL
    Date Cleared
    1999-12-23

    (55 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip which is used to facilitate the urethral introduction of the catheter.

    Device Description

    The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K993651 letter and the "Indications For Use" form do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a clearance letter from the FDA stating that the O'Neil Sterile Field Intermittent Urinary Catheter is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, experts, adjudication, or MRMC studies from the provided text.

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