BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Imaging, Fluorescence

    PMA: P020008 · Decision Dec 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Imaging, Fluorescence
    Trade Name
    KARL STORZ AUTOFLUORESCENCE SYSTEM
    PMA Number
    P020008
    Device Class
    FDA Class 3
    Product Code
    MRK
    Generic Name
    SYSTEM, IMAGING, FLUORESCENCE
    Medical Specialty
    Unknown
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 12, 2002
    Date Received
    March 7, 2002
    Expedited Review
    N
    Docket Number
    03M-0011

    Advisory Committee Statement

    APPROVAL FOR THE KARL STORZ AUTOFLUORESCENCE SYSTEM. THE KARL STORZ AUTOFLUORESCENCE SYSTEM IS INDICATED FOR USE IN WHITE LIGHT AND AUTOFLUORESCENCE BRONCHOSCOPY TO IDENTIFY AND LOCATE ABNORMAL BRONCHIAL TISSUE FOR BIOPSY AND HISTOLOGICAL EVALUATION. IT IS INDICATED IN PATIENTS WHO: 1) ARE SUSPECTED OF HAVING BRONCHOGENIC CARCINOMA AND ARE SCHEDULED FOR A BRONCHOSCOPY AS PART OF A STANDARD DIAGNOSTIC STAGING OR WORK-UP 2) HAVE BEEN PREVIOUSLY DIAGNOSED WITH LUNG CANCER AND WHO ARE AT HIGH RISK FOR RECURRENCE 3) HAVE ABNORMAL SPUTUM CYTOLOGY 4) HAVE ABNORMAL CHEST X-RAY, CT SCAN OR SIMILAR TECHNOLOGY.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRK System, Imaging, Fluorescence