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

    Sure-Fine Insulin Syringes

    K Number: K250510 · Decision Oct 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    7
    Review Days
    236

    Basic Information

    Device Name
    Sure-Fine Insulin Syringes
    K Number
    K250510
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shina Med Corporation
    Date Received
    February 21, 2025
    Decision Date
    October 15, 2025
    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 Shina Med Corporation

    K Number Device Name
    K250658 SureFine Pen Needle
    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