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510(k) Data Aggregation

    K Number
    K091600
    Device Name
    DIRECTVISION GUIDE SYSTEM
    Manufacturer
    PERCUVISION LLC
    Date Cleared
    2009-08-25

    (83 days)

    Product Code
    FGC
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FGC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.
    Device Description
    The DirectVision™ Guide System is comprised of two (2) distinct components: a flexible semirigid microendoscope, and a handheld camera with integral LED illumination and camera control unit (CCU). The microendoscope is designed to work with the Schoelly Imaging Inc. FSC2 light source and CCU (K090601). The DirectVision TM Guide System is indicated for use in the endoscopic examination of the urethra and bladder, when placing the PercuCath™ Urologic Catheter (K090262). The catheter provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use. The microendoscope coupler is connected to the cleared camera and integral light source such that the light source is collinear with the light fiber optic bundle and the camera is collinear with the image fiber optic bundle. The image transmitted through the image fiber optic bundle to the camera is then displayed on a monitor accessory for the clinician to view.
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