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

    HURWITZ AMNIOCENTESIS NEEDLE

    K Number: K854725 · Decision Mar 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    19
    Applicant Total
    632
    Review Days
    115

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    Basic Information

    Device Name
    HURWITZ AMNIOCENTESIS NEEDLE
    K Number
    K854725
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    November 22, 1985
    Decision Date
    March 17, 1986
    Product Code
    HIO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

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