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510(k) Data Aggregation

    K Number
    K250262
    Device Name
    GO-PEN®
    Manufacturer
    GO-Pen ApS
    Date Cleared
    2025-04-24

    (85 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    GO-Pen ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.
    Device Description
    GO-PEN® is an assembly of a durable pen-shaped dosing unit with a special disposable sterile reservoir that fits into the dosing unit. The GO-PEN® device can only be used with NovoLog® U-100 insulin aspart for injection. The user is intended to fill up the disposable reservoir with 1.3 mL of insulin from a 10 ml vial and mount it on the dosing unit. The GO-PEN® device allows the user to set the desired dose from 1 to 60 Units in 1 Unit increments using the dial feature. Once the GO-PEN® disposable reservoir is filled, it can be used over a period of up to 3 days at room temperature (max. 30°C/86°F) for multiple injections of precise doses of insulin. When the reservoir is empty or the time has been exceeded, the reservoir must be discarded, and a new sterile reservoir is used for the next filling. GO-PEN® is used with standard single-use hypodermic needles with a luer lock which are supplied separately by the user.
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