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510(k) Data Aggregation

    K Number
    K991904
    Device Name
    MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-08-31

    (88 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION OF JMS NEEDLES AND JMS SYRINGES

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

    JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump. JMS Needle and JMS Syringe must be discarded after one time use.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the JMS Needle and JMS Syringe. It states that the devices are substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies with specific acceptance criteria.

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