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510(k) Data Aggregation

    K Number
    K100533
    Device Name
    VISTA ENDOSCOPE,89 CM, 56CM , SCOUT BLUNT-TIPPED GUIDE- 106 CM, 86 CM, 53 CM, MODELS FG0027, FG0031, FG0029, FG 0028,
    Manufacturer
    VIBRYNT, INC
    Date Cleared
    2011-02-08

    (348 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIBRYNT, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISTA™ Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
    Device Description
    The VISTA Endoscope is a flexible fiberscope that allows for visualization of the thoracic and abdominal cavities. The device is labeled non-sterile and must be sterilized prior to use. The Endoscope may be used with or without the SCOUTTM Blunt-tipped Guide accessory, which aids in Endoscope advancement and steerability. The Guide also has a fluid channel (cannula) that may be used to deliver saline that may be required for irrigation during an endoscopic procedure. The SCOUTTM Guide is a sterile, single-use device, sterilized by electron beam radiation.
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