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510(k) Data Aggregation

    K Number
    K073122
    Device Name
    MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR
    Date Cleared
    2007-11-21

    (15 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K854547,K012646
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended for the injection of medications into or the withdrawal of body fluids from parts of the body below the surface of the skin.

    Device Description

    The devices consist of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

    AI/ML Overview

    This document does not describe an AI/ML powered medical device. It details a 510(k) premarket notification for 30 Gauge Monoject® Hypodermic Needles.

    Therefore, I cannot provide the information requested regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as these concepts are specifically relevant to the evaluation and validation of AI/ML algorithms, not hypodermic needles.

    The document indicates that the device's substantial equivalence is based on its conformity to recognized safety and performance consensus standards for needles (ISO 7864, ISO 9626, ISO 594-1, ISO 594-2, and ISO 6009) and its similarity in design and intended use to predicate devices.

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