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

    ULTROID HEMORRHOID MANAGEMENT SYSTEM

    K Number: K023706 · Decision Jan 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    ULTROID HEMORRHOID MANAGEMENT SYSTEM
    K Number
    K023706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultroid, LLC
    Date Received
    November 4, 2002
    Decision Date
    January 14, 2003
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Ultroid, LLC

    K Number Device Name
    K030315 MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM