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

    5 STAR MEDICAL ENDOSCOPE

    K Number: K963354 · Decision Sep 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    378

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    Basic Information

    Device Name
    5 STAR MEDICAL ENDOSCOPE
    K Number
    K963354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Five Star Medical, Inc.
    Date Received
    August 26, 1996
    Decision Date
    September 8, 1997
    Product Code
    ODF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ODF Mini Endoscope, Gastroenterology-Urology

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    Other Clearances by Five Star Medical, Inc.

    K Number Device Name
    K960876 FIVE STAR BRONCHOSCOPE