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

    FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE

    K Number: K872597 · Decision Jul 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    26

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    Basic Information

    Device Name
    FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE
    K Number
    K872597
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Dianon Systems, Inc.
    Date Received
    July 2, 1987
    Decision Date
    July 28, 1987
    Product Code
    DWO
    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
    DWO Needle, Biopsy, Cardiovascular

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    Other Clearances by Dianon Systems, Inc.

    K Number Device Name
    K882105 CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM