LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012583
    Device Name
    ACUGLIDE BRAND ACUPUNCTURE NEEDLES
    Manufacturer
    HELIO MEDICAL SUPPLIES, INC.
    Date Cleared
    2001-12-11

    (123 days)

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

    ACUGLIDE BRAND ACUPUNCTURE NEEDLES

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

    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

    I am sorry, but based on the provided text, I cannot provide the requested information. The text is a letter from the FDA regarding the 510(k) premarket notification for "AcuGlide brand Acupuncture Needles." It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    However, the document does NOT contain:

    • A table of acceptance criteria or reported device performance.
    • Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, expert information, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
    • Information on training sets or how ground truth was established for any studies.

    The letter is a regulatory approval document and does not delve into the technical details of performance studies.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1