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510(k) Data Aggregation

    K Number
    K192518
    Device Name
    Reusable Monopolar Active Cord
    Manufacturer
    Date Cleared
    2019-10-25

    (42 days)

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

    US Endoscopy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
    Device Description
    The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory. The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.
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    K Number
    K180731
    Device Name
    Ultramatrix EUS Balloon
    Date Cleared
    2018-04-19

    (30 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    (US Endoscopy)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.
    Device Description
    Not Found
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