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510(k) Data Aggregation

    K Number
    K251731

    Validate with FDA (Live)

    Device Name
    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
    Manufacturer
    Karl Storz SE & Co.Kg
    Date Cleared
    2025-12-05

    (182 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Special
    Panel
    Ear Nose & Throat
    Age Range
    All
    Reference & Predicate Devices
    K212656
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

    E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

    Device Description

    The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile (FIVE-S) is sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor (when using the Image1 S CCU), where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into the compatible CCU (Camera Control Unit) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

    AI/ML Overview

    N/A

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