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510(k) Data Aggregation

    K Number
    K152702
    Device Name
    ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
    Date Cleared
    2016-02-18

    (150 days)

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

    ENT BIOTECH SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENT Biotech Solutions Tissue Removal Device (Elasso™) is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).
    Device Description
    The ENT Biotech Solutions tissue removal device (also referred to as the "Elasso™") is a single-use, surgical accessory, used with a recommended electrosurgical generator (not supplied by ENT Biotech Solutions, INC) and associated equipment (monopolar cord and patient return electrode). The Elasso device configuration is similar to a standard forceps geometry (patterned after the commercially available reference device, St. Clair Forceps), but with an integrated loop electrode at the distal tip of one of the forceps. The proximal end contains a single banana pluq. for connection to the generator. The hand piece is operated by the generator's footswitch controller. The Elasso™ is a single-use, sterile packaged device.
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