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    K Number
    K233789
    Device Name
    8Q10 Surclear Smoke Plume Evacuation System
    Manufacturer
    Surnic Corporation
    Date Cleared
    2024-04-10

    (134 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surnic Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.
    Device Description
    The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.
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    K Number
    K203522
    Device Name
    Surn5 Electrosurgical Argon Beam Generator and Accessories
    Manufacturer
    Surnic Corporation
    Date Cleared
    2021-02-22

    (83 days)

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

    Surnic Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surns Electrosurgical Argon Beam Generator and Accessories are indicated for monopolar or bipolar surgery to achieve argon beam and cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.
    Device Description
    Surn5 electrosurgical argon beam Generator and accessories have Monopolar Pure cut, Monopolar Bland Cut, Argon Beam, Bipolar functions. Surn5 electrosurgical argon beam Generator and accessories consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the device. The output is controlled by foot or hand switch.
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