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

    HYPODERMIC NEEDLES, SINGLE LUMEN

    K Number: K911397 · Decision May 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    130
    Applicant Total
    8
    Review Days
    52

    Basic Information

    Device Name
    HYPODERMIC NEEDLES, SINGLE LUMEN
    K Number
    K911397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    POPPER & SONS, INC.
    Date Received
    March 29, 1991
    Decision Date
    May 20, 1991
    Product Code
    FCG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCG Biopsy Needle

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FCG), ordered by most recent decision date.

    EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Precision GI

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ClearTip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EndoDrill® Model X

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Disposable Coaxial Biopsy Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by POPPER & SONS, INC.

    K Number Device Name
    K843830 J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI
    K843690 ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
    K842406 WESCOTT TYPE BIOPSY NEEDLE
    K841301 GARDNER TYPE BONE MARROW NEEDLE
    K841300 ANTRUM NEEDLE-WOLF TYPE
    K841299 BIERMAN BIOPSY NEEDLE
    K840168 WESTERMAN-JENSEN BIOPSY NEEDLE