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

    BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle

    K Number: K210978 · Decision Dec 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    134
    Review Days
    265

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    Basic Information

    Device Name
    BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
    K Number
    K210978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    April 1, 2021
    Decision Date
    December 22, 2021
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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