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510(k) Data Aggregation

    K Number
    K990020
    Device Name
    TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    1999-06-24

    (171 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED FOR THE DETECTION AND CONFIRMATION OF THE PLACEMENT OF THE EPIDURAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPIDURAL ANESTHESIA. THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY. IT IS NOT INTENDED FOR ASPIRATION OR INJECTION.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) premarket notification approval letter and the "Indications For Use" statement for the TE ME NA Loss of Resistance Syringe, 10CC. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means that the FDA determined the new device is as safe and effective as a legally marketed predicate device, without requiring extensive clinical trials or performance studies that would typically be detailed in a Device Performance section.

    Therefore, I cannot provide the requested information based on the given input.

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