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510(k) Data Aggregation

    K Number
    K023019
    Device Name
    VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
    Manufacturer
    VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
    Date Cleared
    2002-12-10

    (90 days)

    Product Code
    FGI
    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

    VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. With the aid of a ureterocystoscope, a radiopaque medium is injected into the ureter for radiologic imaging.

    The VOMED urethra olives are accessories of male urethrographic catheters. They are placed temporarily on the external end of the penis to guide the insertion of the catheters and to facilitate the injection of the opaque substance.

    The devices are indicated for diagnostic and therapeutic urologic procedures.

    Device Description

    VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. They are accessories of male urethrographic catheters.

    AI/ML Overview

    The provided text is a 510(k) summary for VOMED Urethra Olive Models. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a letter from the FDA determining substantial equivalence for the specified device. It focuses on regulatory aspects such as classification, general controls, and compliance with the Federal Food, Drug, and Cosmetic Act. It also includes the official "Indications for Use" for the VOMED Urethra Olives.

    Therefore, I cannot extract the requested information from the provided text.

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