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510(k) Data Aggregation

    K Number
    K242741
    Device Name
    ACE Cannula
    Manufacturer
    Ace Medical Industry Co., Ltd.
    Date Cleared
    2025-01-08

    (119 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ace Medical Industry Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE Cannula is intended to inject fluids intradermally.
    Device Description
    The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.
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