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510(k) Data Aggregation

    K Number
    K961178
    Device Name
    KARL STORZ INTUBATION FIBERSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-05-14

    (49 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.

    Device Description

    The Karl Storz intubation fiberscope consists of a focusing ocular lens, a moveable eyepiece, a rigid curved stainless steel shaft that houses the fiber optic imaging and illumination system, a distal objective lens, a channel for insufflation of oxygen, a sliding cap to accommodate endotracheal catheters of various sizes and a connection for a fiber optic light cable.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a Karl Storz intubation fiberscope, focusing on its description, indication, and substantial equivalence to predicate devices. It does not include details about specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/device performance evaluation.

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