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510(k) Data Aggregation

    K Number
    K253184

    Validate with FDA (Live)

    Date Cleared
    2026-03-25

    (180 days)

    Product Code
    Regulation Number
    874.4760
    Age Range
    18 - 999
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Video Rhinolaryngoscope SP11A is a sterile, single-use, flexible endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is used in conjunction with the Endoscopic Video Processor (Models M110B) to provide the images. The endoscope is intended for use in a hospital environment. It is designed for use in adults.

    The Endoscopic Video Processor M110B is used in conjunction with corresponding Wesee endoscopes to process and display images for endoscopic procedure.

    Device Description

    The Video Rhinolaryngoscope System consists of the Disposable Video Rhinolaryngoscope SP11A, Video Cable, Endoscopic Video Processor M110B and Accessories. To avoid risk of cross-contamination, the insertion part of the Disposable Video Rhinolaryngoscope SP11A is designed as a sterile, single use device. And other parts of the subject system are reusable device.

    The endoscope has a long, thin, flexible tube to enter the patient's body, and the CMOS sensor embedded in the distal end of the endoscope is used to capture video signals of body cavity and real-time transfer the video signals to the endoscopic video processor through the video cable. The endoscopic video processor receives and processes the video signals according to the surgeon's operation on the control panel of the video image processor. Meanwhile, the light emitting diode (LED) lamp of the endoscope provides an illumination for the body cavity and the clear video is displayed on the monitor.

    AI/ML Overview

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