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510(k) Data Aggregation

    K Number
    K073207
    Device Name
    OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Date Cleared
    2008-05-08

    (177 days)

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

    CELON AG MEDICAL INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy.
    Device Description
    The Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy. Olympus ESG-100: The ESG-100 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. It has two displays. One display shows the selected power level, the other display shows the currently selected program mode. Buttons are used to set the power level or to change the modes. Different connectors allow connecting mono- and bipolar electrosurgical instruments, a neutral electrode, a footswitch, or an ancillary pump. The maximum output power is 120 W. Olympus AFU-100: The AFU-100 peristaltic flushing pump employs tubing to deliver fluid to the tissue/mucosa. Sterile liquids (e.g. isotonic saline solution) thus remain sterile, provided that a sterile tube set is used. The maximum flow rate is 270 ml and 600 ml per minute with two different tube sets offered as single use items. In addition, three memory buttons provide fast access to preset flow levels. The AFU-100 can be connected to the electrosurgical generator ESG-100 by an interface, allowing operation of the peristaltic pump unit by a special button of the electrosurgical unit's footswitch. The pump rotor is equipped with a protective cover, which automatically stops the rollers from rotating if it is opened while the peristaltic pump unit is activated, and thus prevents possible injuries. Accessories: A-Cord, P-Cord, Footswitch (ESG-100), Footswitch (AFU-100), Pump Tube.
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    K Number
    K032838
    Device Name
    CELON ENT SYSTEM
    Manufacturer
    CELON AG MEDICAL INSTRUMENTS
    Date Cleared
    2003-09-26

    (15 days)

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

    CELON AG MEDICAL INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This application system, comprising the CelonLab ENT power control unit and the CelonProBreath, CelonProSleep, and CelonProSleep PLUS bipolar coagulation electrodes, is indicated for ablation and coagulation of soft tissue in otorhinolaryngology (ENT) surgery including: CelonProBreath: Submucosal tissue shrinkage for nasal airway obstruction by reduction of hypertrophic nasal turbinates CelonProSleep: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring CelonProSleep PLUS: Submucosal tissue shrinkage and tissue coagulation in the uvula/soft palate for the treatment of snoring The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
    Device Description
    The Celon ENT System is comprised of a power control unit (CelonLab EN7) and bipolar coagulation electrodes. The CelonLab ENT power control unit delivers a bipolar output via the bipolar coagulation electrodes of type CelonProBreath, CelonProSleep, and CelonProSleep PLUS. A neutral electrode (return conductor) is not required. The power control unit is user-friendly with a user display showing all the necessary process parameters. After switching on the equipment, the user selects the level of power and activates the radio frequency (RF) current by depressing the foot switch. The power control unit delivers an acoustic signal as an indicator of the coaqulation status. Usually, general electrosurgical units have a fixed activation tone. However, in the case of the CelonLab ENT power control unit, the frequency of the acoustic signal is proportional to the tissue impedance. This permits acoustic monitoring of the coagulation status by the operator, since the latter is directly correlated with the impedance. If the impedance increases above a certain limit, signifying that the coagulation process is complete, this is additionally indicated by a clock pulsed sound and the power output is ceased automatically. Overdose effects in the treated tissue area are excluded by this power control function. The procedure time will be set automatically by the power control unit. The time interval between activation of the power control unit and the end of the coagulation procedure depends on applicator type, tissue properties and power setting, and can vary between 3 seconds and several minutes. Accessories included with the power control unit include a line power cable and single pedal foot pedal (CelonFootSwitch).
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