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510(k) Data Aggregation

    K Number
    K172978
    Device Name
    SurgeoBite
    Manufacturer
    Surgovations LLC
    Date Cleared
    2017-12-22

    (86 days)

    Product Code
    JXL
    Regulation Number
    882.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgovations LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
    Device Description
    The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.
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