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510(k) Data Aggregation

    K Number
    K102921
    Device Name
    ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
    Manufacturer
    BEMA-GMBH & CO. KG
    Date Cleared
    2011-12-20

    (445 days)

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

    **BEMA-GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.
    Device Description
    Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip.
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