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

    1/2 CM REAR TIP EXTENDER (RTE)

    K Number: K882297 · Decision Jun 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    21
    Applicant Total
    72
    Review Days
    15

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    Basic Information

    Device Name
    1/2 CM REAR TIP EXTENDER (RTE)
    K Number
    K882297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Medical Systems, Inc.
    Date Received
    June 2, 1988
    Decision Date
    June 17, 1988
    Product Code
    FHN
    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
    FHN Ligator, Hemorrhoidal

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