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510(k) Data Aggregation

    K Number
    K251986
    Device Name
    AUXILIARY WATER TUBE MAJ-855
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-09-26

    (91 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K220395,K232997
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AUXILIARY WATER TUBE MAJ-855 is intended to be used to provide sterile water, detergent solution, disinfectant solution, water, and alcohol for irrigation through the auxiliary water channel of compatible endoscopes.

    Device Description

    The Auxiliary Water Tube MAJ-855 is used in endoscopic procedures to flush sterile water through the auxiliary water channel to wash the endoscopic field of view. Sterile water for washing the mucosa can be provided either manually by use of a syringe or automatically via a flushing pump. The MAJ-855 can be used both during an endoscopic procedure and reprocessing (i.e. pre-cleaning, manual cleaning and manual disinfection).

    The Auxiliary Water Tube MAJ-855 is a reusable device, provided to the user in a non-sterile condition and must be reprocessed prior to first use and following each use (i.e., after each patient exam).

    AI/ML Overview

    N/A

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