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

    BIOPSY NEEDLE GUIDE KIT, STERILE

    K Number: K871503 · Decision Jul 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    526
    Registration Numbers
    526
    Same Product Code
    18
    Applicant Total
    10
    Review Days
    84

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    Basic Information

    Device Name
    BIOPSY NEEDLE GUIDE KIT, STERILE
    K Number
    K871503
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Amedic USA
    Date Received
    April 17, 1987
    Decision Date
    July 10, 1987
    Product Code
    FZX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FZX Guide, Surgical, Instrument

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