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

    SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

    K Number: K133867 · Decision Feb 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    28
    Review Days
    47

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
    K Number
    K133867
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Europe N.V.
    Date Received
    December 20, 2013
    Decision Date
    February 5, 2014
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.

    iiSure Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PuraCath Firefly Needleless Connector IT (9005)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Pump Infusion Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EZ™ IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    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
    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. →