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

    AMS FOREIGN BODY EXTRATOR

    K Number: K972091 · Decision Aug 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    51
    Applicant Total
    72
    Review Days
    86

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    Basic Information

    Device Name
    AMS FOREIGN BODY EXTRATOR
    K Number
    K972091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4680
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    June 4, 1997
    Decision Date
    August 29, 1997
    Product Code
    FFL
    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
    FFL Dislodger, Stone, Basket, Ureteral, Metal

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