BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SureFine Pen Needle

    K Number: K250658 · Decision Apr 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    SureFine Pen Needle
    K Number
    K250658
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shina Med Corporation
    Date Received
    March 5, 2025
    Decision Date
    April 3, 2025
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Shina Med Corporation

    K Number Device Name
    K250510 Sure-Fine Insulin Syringes
    K231165 Shina Syringe; Shina Safety Syringe
    K210848 Sure-Fine Insulin Syringes
    K191531 Sure-Fine Insulin Syringes
    K152879 Sure-Fine Insulin Syringes
    K152877 SureFine Pen Needle