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

    VENOJECT LUER ADAPTER

    K Number: K041358 · Decision May 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    28
    Review Days
    7

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    Basic Information

    Device Name
    VENOJECT LUER ADAPTER
    K Number
    K041358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Europe N.V.
    Date Received
    May 21, 2004
    Decision Date
    May 28, 2004
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    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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    Other Clearances by Terumo Europe N.V.

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    K243581 K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
    K230951 Terumo Injection Filter Needle (NF-3013RBKE05M)
    K212095 SurGuard3 Safety Hypodermic Needle
    K192057 K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall
    K161606 Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
    K151398 K-Pack II Needle - 29G x 5/16 Thin Wall
    K150263 K-Pack II Needle-21G x 2
    K133894 SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)
    Search all 28 clearances from Terumo Europe N.V. →