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510(k) Data Aggregation

    K Number
    K060392
    Device Name
    ASP TITANIUM
    Manufacturer
    SEDATELEC
    Date Cleared
    2006-04-26

    (70 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 :

    ASP TITANIUM

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

    The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

    Device Description

    The device consists of a solid, titanium needle.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot provide the requested information based on the given input. The categories in your request are relevant to the evaluation of AI/ML-driven medical devices, which this document is not about.

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