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    K Number
    K250409
    Device Name
    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-21

    (250 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K962925
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DISPOSABLE BALLOON CATHETER B5-2Q, B7-2Q/2LA have been designed to be used with Olympus endoscopes to inject contrast medium into the biliary or pancreatic track. They can also be used for retrieval of biliary or pancreatic stones.

    Device Description

    The Balloon Catheters are constructed of an inflatable balloon, tube, branch, injection port, air feeding port, and stopcock.

    Prior to use, a sterile syringe is attached to the air feeding port and injects air into the tube to inflate the balloon to the specified volume to confirm that the balloon inflates properly. The balloon is then deflated completely, and the tube is inserted into the instrument channel of the endoscope and advanced to the target area, where the balloon is inflated to allow for biliary or pancreatic stone removal or contrast medium injection through the injection port. When the procedure is completed, the balloon is deflated and the tube is removed from the patient.

    AI/ML Overview

    N/A

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