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510(k) Data Aggregation

    K Number
    K973254
    Device Name
    J-TIP INJECTOR
    Manufacturer
    NATIONAL MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-11-24

    (87 days)

    Product Code
    KZE
    Regulation Number
    880.5430
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Injector used for the subcutaneous administrations of xylocaine or calcimar/calcitonin which are appropriate for subcutaneous injection using jet injection or needleless injection systems. For subcutaneous injections only. The device serves as an alternative to the subcutaneous delivery of xylocaine or calcimar/calcitonin medications with needle and syringe.

    Device Description

    J-Tip Needleless Injection System

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding the "J-Tip Needleless Injection System". It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving device performance in the manner requested.

    Therefore, I cannot provide the detailed information about acceptance criteria and a performance study based on this document. The document confirms that the device is "substantially equivalent" to previously marketed devices, which is a regulatory determination, not a clinical performance validation against specific acceptance criteria.

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