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

    E-Z-EM(R) LUFKIN BIOPSY NEEDLES

    K Number: K882601 · Decision Jul 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    47
    Applicant Total
    56
    Review Days
    31

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    Basic Information

    Device Name
    E-Z-EM(R) LUFKIN BIOPSY NEEDLES
    K Number
    K882601
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    June 24, 1988
    Decision Date
    July 25, 1988
    Product Code
    GDM
    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
    GDM Needle, Aspiration And Injection, Reusable

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    K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
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    K013219 PROTOCO2L INSUFFLATOR MODEL 6400
    K011160 E-Z EM PERCUPUMP 2001 CT INJECTOR
    K974621 PERCUPUMP II WITH EDA
    Search all 56 clearances from E-Z-Em, Inc. →