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510(k) Data Aggregation

    K Number
    K980465

    Validate with FDA (Live)

    Device Name
    OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1998-04-21

    (75 days)

    Product Code
    FDT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K954451
    Predicate For
    K024033
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TJF-140R/JF-140R Duodenovideoscopes: Olympus TJF-140R/JF-140R Duodenovideoscopes have been designed to be used with an Olympus EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy Accessories (Forceps, Brush, Electrosurgical Accessories, etc.), Electrosurgical Unit, and other Ancillary Equipment for endoscopy and endoscopic surgery within the duodenum.

    MAJ-311/MAJ-411 Distal Covers: Olympus MAJ-311 Distal Cover is specifically designed to be attached to the Olympus TJF-140R Duodenovideoscope during an endoscopic procedure. Olympus MAJ-411 Distal Cover is specifically designed to be attached to the Olympus JF-140R Duodenovideoscope during an endoscopic procedure.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for Olympus TJF-140R/JF-140R EVIS Duodenovideoscopes and their accessories, focusing on their substantial equivalence to predicate devices and their intended use. It does not include details on specific performance metrics, clinical studies, or data analysis as requested.

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