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

    ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY

    K Number: K935235 · Decision Mar 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    17
    Applicant Total
    87
    Review Days
    507

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    Basic Information

    Device Name
    ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY
    K Number
    K935235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    November 1, 1993
    Decision Date
    March 23, 1995
    Product Code
    GCM
    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
    GCM Endoscope, Rigid

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