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

    EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle

    K Number: K251089 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    7
    Review Days
    246

    Basic Information

    Device Name
    EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    K Number
    K251089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exelint International, Co.
    Date Received
    April 10, 2025
    Decision Date
    December 12, 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 Exelint International, Co.

    K Number Device Name
    K152183 EXELINT SecureTouch Safety Hypodermic Needle
    K101309 EXELINT ALUMINUM HUB BLUNT NEEDLES
    K020189 EXEL BUTTERFLY SCALP VEIN SET
    K010197 EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
    K003627 EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
    K001496 A.V. FISTULA NEEDLE