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510(k) Data Aggregation

    K Number
    K252572
    Device Name
    Prodeon Urethral Sheath System
    Manufacturer
    Prodeon Medical, Inc.
    Date Cleared
    2025-10-07

    (54 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K243820
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Prodeon Urethral Sheath System is used to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

    Device Description

    The Prodeon Urethral Sheath System comprises a Sheath and Irrigation Valve. The Prodeon Urethral Sheath System is a sterile, single-use, disposable device made of biocompatible materials with a long history of use in medical devices. The Prodeon Urethral Sheath System is a conduit for facilitating the introduction of endoscopes and other instruments into the urinary tract. The Prodeon Urethral Sheath System includes an Irrigation Valve that attaches to the cystoscope luer and allows the introduction of a tool/instrument and irrigation into the channel of a cystoscope.

    The Prodeon Urethral Sheath System is available in one size.

    AI/ML Overview

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