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510(k) Data Aggregation

    K Number
    K231877
    Device Name
    NavaClick Injection System
    Date Cleared
    2023-11-30

    (157 days)

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

    Lineage Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
    Device Description
    The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
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