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

    Entellus Medical Reinforced Anesthesia Needle

    K Number: K163435 · Decision Apr 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    27
    Review Days
    119

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    Basic Information

    Device Name
    Entellus Medical Reinforced Anesthesia Needle
    K Number
    K163435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entellus Medical, Inc.
    Date Received
    December 7, 2016
    Decision Date
    April 5, 2017
    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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