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510(k) Data Aggregation

    K Number
    K251111
    Device Name
    Cary
    Manufacturer
    Excitus AS
    Date Cleared
    2025-05-07

    (26 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excitus AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).
    Device Description
    [Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.
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