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

    Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

    K Number: K244047 · Decision May 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    2
    Review Days
    143

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    Basic Information

    Device Name
    Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
    K Number
    K244047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Venocare, Inc.
    Date Received
    December 31, 2024
    Decision Date
    May 23, 2025
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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