BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUTOMATIC ENDOSCOPE

    K Number: K832458 · Decision Oct 20, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    19
    Review Days
    86

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    Basic Information

    Device Name
    AUTOMATIC ENDOSCOPE
    K Number
    K832458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Endoscopy, Inc.
    Date Received
    July 26, 1983
    Decision Date
    October 20, 1983
    Product Code
    NVE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVE Washer, Cleaner, Automated, Endoscope

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    Other Clearances by American Endoscopy, Inc.

    K Number Device Name
    K853274 AMERICAN DILATATION SYSTEM
    K841384 PROXIMA 1 PH MONITOR
    K833491 ENDO BITE BLOCK
    K840818 BIOPSY FORCEPS
    K833859 TAMPONADE BALLOON CUFF
    K833492 PERCUTANEOUS ENDOSCOPIC GASTROSCOPY
    K821818 RETRIEVAL BALLOONS
    K821819 PIGTAIL STENTS
    K822062 BALL TIP COAGULATING ELECTRODES
    K821817 PIGTAIL NASAL CATHETERS
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