LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K964861
    Device Name
    ACUPUNCTURE NEEDLES
    Manufacturer
    C.A.M. SUPPLY, INC.
    Date Cleared
    1997-05-29

    (176 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The acupuncture needles devices licensed are used by practitioners which are intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Acupuncture Needles, allowing them to be marketed based on substantial equivalence to existing devices. As such, it does not contain the detailed information about acceptance criteria and clinical study results typically found in a Premarket Approval (PMA) application or a more extensive 510(k) submission summary.

    Therefore, I cannot provide the requested information. This document primarily focuses on regulatory clearance based on substantial equivalence, rather than a performance study demonstrating acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1