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510(k) Data Aggregation

    K Number
    K251089

    Validate with FDA (Live)

    Date Cleared
    2025-12-12

    (246 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended to be used:

    • to inject fluids into, or withdraw fluids from, the body.
    • to administer and/or withdraw (aspirate) fluids/drugs.

    These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device.

    Device Description

    EXEL Disposable Syringes are piston syringes of a three-piece design, consisting of a barrel, plunger, and gasket. The tip of the syringe has a male connector (nozzle) for connection to other devices. The barrel includes bold, clear scale markings (graduations) for accurate dosage measurement. The EXEL Disposable Syringe models are differentiated by volume (Luer Lock, Luer Slip, or Luer Slip Eccentric). and by the type of connector at the syringe tip (Luer Lock, Luer Slip). Luer Slip connectors may be centric or eccentric (i.e., off-centered) with a push-on design, while Luer Lock connectors provide a secure threaded attachment to needles or other devices. Some models feature extended graduation markings beyond the nominal capacity, differentiated with smaller graduation marks.

    EXEL Hypodermic Needles are single-lumen hypodermic needles which are sterile and intended for single use. They consist of a hollow, bevel-edged metal tube (the cannula) that is sharpened at one end and joined to a female connector (the hub) at the other end. The EXEL Hypodermic Needle models are differentiated by needle gauge and needle length.

    EXEL Disposable Syringes with Needles consist of a piston syringe connected to a hypodermic needle. The models are differentiated by the needle gauge, needle length, syringe volume, and connection type (Luer Lock, Luer Slip, or permanently attached).

    The EXEL Disposable Syringe with SecureTouch Safety Needle features a manually activated safety shield that covers the needle tip immediately after withdrawal to reduce the risk of needlestick injury.

    All subject devices are operated manually.

    AI/ML Overview

    N/A

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