BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GUARDIAN FORCEP

    K Number: K893636 · Decision Apr 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    188
    Registration Numbers
    188
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    332

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    Basic Information

    Device Name
    GUARDIAN FORCEP
    K Number
    K893636
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Endo-Scientific, Inc.
    Date Received
    May 12, 1989
    Decision Date
    April 9, 1990
    Product Code
    FCL
    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
    FCL Forceps, Biopsy, Non-Electric

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