LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960876
    Device Name
    FIVE STAR BRONCHOSCOPE
    Manufacturer
    FIVE STAR MEDICAL, INC.
    Date Cleared
    1996-05-08

    (65 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K960876
    Why did this record match?
    Device Name :

    FIVE STAR BRONCHOSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 5 Star Medical bronchoscope is intended for use in the direct visualization and diagnosis in the trachea and lungs.

    Device Description

    A description of the Bronchoscope's components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.

    AI/ML Overview

    This document, K960876, is a 510(k) summary for a Bronchoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Microvasive Visicath) based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    Therefore, I cannot populate the table or answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, or study methodologies. The provided text is a regulatory submission for pre-market notification, not a clinical or performance evaluation report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1