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510(k) Data Aggregation

    K Number
    K970465
    Device Name
    BOUSER'S URINAL
    Manufacturer
    GENERAL POLYMERS
    Date Cleared
    1997-12-18

    (314 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL POLYMERS

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

    To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.

    Device Description

    Not Found

    AI/ML Overview

    The provided document describes a 510(k) submission for a medical device: "Bouser's Urinal". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes the intended use statement for the device.

    Therefore, I cannot provide the requested information based on this document.

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