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510(k) Data Aggregation

    K Number
    K992485
    Device Name
    MONOPOLAR ELECTRODES AND CABLES
    Manufacturer
    Date Cleared
    1999-08-27

    (32 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    US ENDO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Monopolar Electrodes and Accessories are indicated when Endoscopy is indicated, used primarily to coagulate tissue, for use with HF Electrosurgical Units Targeted Anatomical sites include primarily, the Abdominal (suprapubic) region. The device is reusable, non-sterile, for use as follows: 1. Spatula tip-Dissection-Coagulation & manipulation of tissue. 2. L-Hook tip-Dissection & manipulation 3. J-Hook tip-Core out with a knife-cutting effect (ablation) 4. Knife-tip-Coagulate with scalpel-like cutting 5. Button/Needle-tip-Spot coagulation
    Device Description
    Monopolar Electrodes and Accessories
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