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510(k) Data Aggregation

    K Number
    K222429
    Device Name
    Ellusa Reusable Bipolar Cable
    Manufacturer
    Ellusa, LLC
    Date Cleared
    2022-09-09

    (29 days)

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

    Ellusa, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellusa Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.
    Device Description
    The subject device, Ellusa Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.
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    K Number
    K222425
    Device Name
    Ellusa Reusable Neutral Plates
    Manufacturer
    Ellusa, LLC
    Date Cleared
    2022-09-08

    (28 days)

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

    Ellusa, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellusa Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.
    Device Description
    The Ellusa Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of a reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.
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    K Number
    K202558
    Device Name
    Ellusa Bipolar Wands
    Manufacturer
    Ellusa, LLC
    Date Cleared
    2020-11-02

    (59 days)

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

    Ellusa, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.
    Device Description
    The Ellusa Bipolar Wand family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Ellusa Bipolar Wands is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Ellusa line of highfrequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Ellusa Bipolar Wand emits RF energy generated according to settings established on the Ellusa Generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single use only. The devices are intended for transient contact with the patient and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization.
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    K Number
    K202562
    Device Name
    Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set
    Manufacturer
    Ellusa, LLC
    Date Cleared
    2020-11-02

    (59 days)

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

    Ellusa, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures.
    Device Description
    The Ellusa Generators are radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device is designed to enable the performance of monopolar and bipolar functions for cutting, coagulation, and hemostasis in conjunction with separately-marketed electrosurgical accessories and ancillary equipment which have been developed for mutually- exclusive use with the Ellusa line of generators. All selections are effected through push buttons and lamps, which give the operator feedback of status. The power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and /or hand switches. Ellusa Electrodes are used with the Ellusa Generator. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellusa family of electrodes is available in various shapes and sizes depending on the need of the surgeon. The devices are available in classic alloys (Tungsten, brass, stainless steel). These devices are designed to comply with international safety standards including applicable IEC series electrical safety standards.
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