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510(k) Data Aggregation

    K Number
    K021998
    Device Name
    HORIZONS CYTOLOGY BRUSH
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2002-07-12

    (23 days)

    Product Code
    FDX
    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

    Horizons Cytology Brush is intended to be used in the flexible endescope to collect cell sampling, or to perform surveillance cultures.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the "Horizons Cytology Brush Endoscopic Accessory." It indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

    However, the provided document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance letter, not a scientific study report.

    Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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