BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

    K Number: K952350 · Decision Jul 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)
    K Number
    K952350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promedical , Ltd.
    Date Received
    May 19, 1995
    Decision Date
    July 17, 1995
    Product Code
    LWE
    Advisory Committee
    Unknown
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWE Bone Marrow Collection/Transfusion Kit

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    Other Clearances by Promedical , Ltd.

    K Number Device Name
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    K951598 PRO-B BIOPSY NEEDLE
    K944944 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
    K944942 BREAST LESION LOCALIZATION NEEDLE