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510(k) Data Aggregation

    K Number
    K990519
    Device Name
    PHOENIX EPIDURAL & SPINAL NEEDLES
    Manufacturer
    MYCO MEDICAL SUPPLIES, INC.
    Date Cleared
    2000-06-02

    (470 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHOENIX EPIDURAL & SPINAL NEEDLES

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

    Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

    Device Description

    "Phoenix" Epidural and Spinal Needles.

    AI/ML Overview

    The provided text is a 510(k) clearance letter for "Dr. Japan's Phoenix Brand Spinal and Epidural Needles" and related documentation, dated June 2, 2000. It concerns the substantial equivalence of this device to legally marketed predicate devices.

    This type of document (a 510(k) clearance letter from the FDA) does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. It confirms that the device has been found substantially equivalent to a predicate device based on the information provided in the 510(k) submission, allowing it to be marketed.

    Therefore, I cannot extract the requested details from the provided text. The document is strictly about the regulatory clearance, not the technical performance details of a new device's study.

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