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510(k) Data Aggregation

    K Number
    K011552
    Device Name
    UROLOGICAL CATHETER
    Manufacturer
    APOGEE MEDICAL, INC.
    Date Cleared
    2001-07-18

    (61 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
    Device Description
    AI/ML Overview
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    K Number
    K992137
    Device Name
    UROLOGICAL CATHETER
    Manufacturer
    APOGEE, INC.
    Date Cleared
    1999-09-03

    (71 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K160795
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Apogee Medical,Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder

    Device Description

    Urinary Catheter

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for the Apogee Medical, Inc. Urological Catheter. This document does not contain information about acceptance criteria, device performance studies, or details about AI algorithms. It is a regulatory clearance document.

    Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study is not present in the provided text.

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