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510(k) Data Aggregation

    K Number
    K243232
    Device Name
    GripMate
    Manufacturer
    Synthon Hispania S.L.
    Date Cleared
    2024-12-02

    (54 days)

    Product Code
    KZH
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synthon Hispania S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½'' fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
    Device Description
    The GripMate™ is a non-sterile, reusable, spring-loaded injection device. The device consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection. The device does not have any fluid path and does not have any contained within the syringe. The user has the option to adjust the needle extension using the device Needle Hider Feature. Injection occurs upon the activation of a trigger button which drives the syringe in a three-step sequence which includes needle penetration, injection and needle cover. Once the injection is completed the device provides visual indication to confirm that the full drug dose has been delivered.
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