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

    MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM

    K Number: K030315 · Decision Feb 27, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    28

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
    K Number
    K030315
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultroid, LLC
    Date Received
    January 30, 2003
    Decision Date
    February 27, 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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNS), ordered by most recent decision date.

    Sphincterotome

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vanquish Water Vapor Ablation Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SureTome™ SW Sphincterotome with DomeTip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Ultroid, LLC

    K Number Device Name
    K023706 ULTROID HEMORRHOID MANAGEMENT SYSTEM