BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE

    K Number: K011242 · Decision Sep 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    90
    Applicant Total
    3
    Review Days
    141

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    Basic Information

    Device Name
    HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
    K Number
    K011242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5580
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acusupply, Inc.
    Date Received
    April 23, 2001
    Decision Date
    September 11, 2001
    Product Code
    MQX
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQX Needle, Acupuncture, Single Use

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    Other Clearances by Acusupply, Inc.

    K Number Device Name
    K011248 CW DISPOSABLE ACUPUNCTURE NEEDLE
    K011247 HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE