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

    BREAST LESION LOCALIZATION NEEDLE

    K Number: K944942 · Decision Nov 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    BREAST LESION LOCALIZATION NEEDLE
    K Number
    K944942
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promedical , Ltd.
    Date Received
    October 7, 1994
    Decision Date
    November 4, 1994
    Product Code
    GDF
    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
    GDF Guide, Needle, Surgical

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    Other Clearances by Promedical , Ltd.

    K Number Device Name
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    K952350 JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
    K951598 PRO-B BIOPSY NEEDLE
    K944944 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE