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510(k) Data Aggregation

    K Number
    K143705
    Device Name
    NeedleCam HD Visualization System
    Manufacturer
    BIOVISION TECHNOLOGIES, LLC
    Date Cleared
    2015-02-20

    (53 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVISION TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeedleCam HD™ Visualization System Indications for Use: The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
    Device Description
    NeedleCam HDTM Visualization System is comprised of an Image Capture Box, a Camera Handpiece (including an LED light source) that captures still images and full resolution video, and External Power Supply. The camera has a quick-release optical connector that adapts to a wide variety of Bio Vision Technologies' surgical endoscopes. The device is used with an endoscope to visualize and illuminate an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures.
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    K Number
    K141326
    Device Name
    NEEDLE VIEW CH SCOPE KITS
    Manufacturer
    BIOVISION TECHNOLOGIES, LLC
    Date Cleared
    2014-10-08

    (140 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVISION TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
    Device Description
    The NeedleView CH is a rigid Fiberoptic scope with a working channel designed for single use. The product consists of a 17,000 pixel coherent silica fiber bundle, 30um diameter light fibers and a stainless steel channel encased in a stainless steel shaft. The effective field of view is 80° in air and 62° in water. The direction of view is 0°. The scope has retaining groves to incorporate a drape that will cover the camera and cord that connects to the Surg View System. The NeedleView CH Scope Kit consists of a fiber-optic based micro-endoscope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length), 12F Cannula (4mm Inner Diameter), 12F Dilator(4mm Diameter), 14Gx127mm Tuohy Needle, 18Gx152mm Tuohy Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.
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    K Number
    K082293
    Device Name
    SURGVIEW INTEGRATED VISUALIZATION SYSTEM
    Manufacturer
    BIOVISION TECHNOLOGIES, LLC
    Date Cleared
    2008-09-09

    (28 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOVISION TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgView™ Integrated Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
    Device Description
    The SurgView™ Integrated Imaging System is a video endoscope/arthroscope imaging system consisting of the following components: 1. A Light Source/Display/Image Capture device that includes a monitor, image processor, Xenon light source, camera unit, and a camera hand piece with integrated fiberoptic cable. 2. A semi-rigid Fiberoptic Scope designed for one time use, in a variety of diameters, lengths, and viewing angles. 3. Supplemental Instruments that can be used interchangeably throughout the procedure. They include a cannula, trocar, obturator, and cannula plug. 4. Procedural Kit that contains a variety of sterile items used to aid in the procedure.
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