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510(k) Data Aggregation

    K Number
    K171043
    Device Name
    Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
    Manufacturer
    Coloplast Corp
    Date Cleared
    2017-12-21

    (258 days)

    Product Code
    EYB
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K021856,K962004
    Why did this record match?
    Reference Devices :

    K021856

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

    Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

    Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

    Device Description

    Ureteric catheters are ethylene oxide sterilized, single use devices intended to restore or maintain drainage of the upper urinary tract and to flush or inject contrast medium or saline during an endoscopic procedure. All ureteric catheters include a connector nut with a Luer fitting. The connector nut is inserted into the proximal end of the catheter allowing the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire.

    Flush Ureteric Catheters and Ureteric Catheters come in three different tip configurations (straight, open coudé with side eyes, open coudé without side eyes). A stylet in included with the catheters to aid during the catheter insertion. The Flush Ureteric Catheters and Ureteric Catheters are supplied in a 74 cm length and diameters range from 3 Fr. to 8 Fr. The Floppy Tip Hydro-coated Ureteric catheters are 70 cm long and have 5,6, and 7 Fr. diameters.

    The Flush Ureteric Catheters and Ureteric Catheters are made from polyether block amide materials. The Floppy Tip Hydro-coated Ureteric catheters are made from polyvinyl chloride (PVC), have a hydrophilic coating over the distal tip (farthest away from the surgeon), and a soft tip which allows for easier insertion and advancement of the catheter. The materials have a radiopaque filler to allow for fluoroscopic visibility.

    AI/ML Overview

    This document describes the performance testing and acceptance criteria for Ureteric catheters, Flush Ureteric catheters, and Floppy Tip Hydro-Coated Ureteric Catheters.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance CriteriaReported Device Performance
    Biocompatibility TestingIn accordance with ISO 10993-1 and FDA guidance for "Biological Evaluation of Medical Devices part I: Evaluation and Testing within a risk management system". Devices categorized as surface contacting devices in contact with mucous membrane for a limited (
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