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510(k) Data Aggregation

    K Number
    K052085
    Device Name
    STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
    Manufacturer
    ASIA-MED GMBH AND CO KG
    Date Cleared
    2005-10-14

    (73 days)

    Product Code
    MQX
    Regulation Number
    880.5580
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES

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

    Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

    Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) from the provided document.

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