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

    DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE

    K Number: K962676 · Decision Oct 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    18
    Applicant Total
    94
    Review Days
    87

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    Basic Information

    Device Name
    DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
    K Number
    K962676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Endoscopy Group, Inc.
    Date Received
    July 9, 1996
    Decision Date
    October 4, 1996
    Product Code
    FGO
    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
    FGO Dislodger, Stone, Flexible

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