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510(k) Data Aggregation

    K Number
    K974493
    Device Name
    FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES
    Manufacturer
    FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH
    Date Cleared
    1998-03-31

    (123 days)

    Product Code
    FDS,FAM,FDF,FDT,FEM
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Provide illumination to, and allow visual observation and/or surgical manipulation of body cavities, hollow organs and canals in the Gastrointestinal tract.

    Device Description

    Fiegert Endotech Flexible Fiberoptic Endoscopes; Fiegert Endotech Flexible Video-Endoscopes

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device's performance. The document is primarily a 510(k) clearance letter from the FDA for "Fiegert Endotech Flexible Fiberoptic Endoscopes, Videoscopes, and Erocam-Pro Color Videocamera, Image Processor and Accessories," indicating that the device is substantially equivalent to a predicate device. It defines the indications for use but does not delve into the specific performance metrics or studies you are asking for.

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