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

    GARDNER TYPE BONE MARROW NEEDLE

    K Number: K841301 · Decision Jun 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    8
    Review Days
    67

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    Basic Information

    Device Name
    GARDNER TYPE BONE MARROW NEEDLE
    K Number
    K841301
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Popper & Sons, Inc.
    Date Received
    March 30, 1984
    Decision Date
    June 5, 1984
    Product Code
    GAA
    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
    GAA Needle, Aspiration And Injection, Disposable

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    Other Clearances by Popper & Sons, Inc.

    K Number Device Name
    K911397 HYPODERMIC NEEDLES, SINGLE LUMEN
    K843830 J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI
    K843690 ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
    K842406 WESCOTT TYPE BIOPSY NEEDLE
    K841300 ANTRUM NEEDLE-WOLF TYPE
    K841299 BIERMAN BIOPSY NEEDLE
    K840168 WESTERMAN-JENSEN BIOPSY NEEDLE