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510(k) Data Aggregation

    K Number
    K022278
    Device Name
    TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
    Manufacturer
    TAIJECT MEDICAL DEVICE CO., LTD.
    Date Cleared
    2002-09-12

    (59 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K023458,K031062,K031909,K040105,K042426
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the TMD™ Safety Syringe. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot extract the requested information from the provided text.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the device's approval is based on substantial equivalence to a predicate device, not on meeting specific acceptance criteria proven by a new clinical study.

    Therefore, I cannot populate the table or answer the specific questions about a study, as that information is not present in this document.

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