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510(k) Data Aggregation

    K Number
    K252631
    Device Name
    Profoject™ Disposable Needle
    Manufacturer
    CMT Health PTE. Ltd.
    Date Cleared
    2025-10-16

    (57 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211214
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Profoject™ Disposable Needle is intended to be used with a Luer lock or Luer slip syringe and injection devices for general purpose fluid injection/aspiration.

    Device Description

    The proposed device, Profoject™ Disposable Needle, consists of a needle tube, a needle hub, and a needle cap. The needle tube is made of stainless steel (SUS 304). The needle hub is made of polypropylene, and its color complies with ISO 6009. The needle cap is also made of polypropylene and does not come into contact with the patient. The conical socket of the needle hub is a Luer connector, compatible with other medical devices featuring Luer connectors. The proposed device is available in a variety of configurations, including different needle gauges, lengths, and wall thicknesses. The proposed device is intended for single use only. It is supplied sterile, sterilized by ethylene oxide (EO) with a sterilization assurance level (SAL) of 10-6.

    AI/ML Overview

    N/A

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