BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH

    K Number: K161606 · Decision Feb 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    28
    Review Days
    245

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    Basic Information

    Device Name
    Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
    K Number
    K161606
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Europe N.V.
    Date Received
    June 10, 2016
    Decision Date
    February 10, 2017
    Product Code
    FMF
    Advisory Committee
    General Hospital
    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
    FMF Syringe, Piston

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    Other Clearances by Terumo Europe N.V.

    K Number Device Name
    K251447 K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
    K243309 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
    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
    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)
    K133867 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
    Search all 28 clearances from Terumo Europe N.V. →