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510(k) Data Aggregation
K Number
K143705Device Name
NeedleCam HD Visualization System
Manufacturer
BIOVISION TECHNOLOGIES, LLC
Date Cleared
2015-02-20
(53 days)
Product Code
HRX, GCJ
Regulation Number
888.1100Why 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
K141326Device Name
NEEDLE VIEW CH SCOPE KITS
Manufacturer
BIOVISION TECHNOLOGIES, LLC
Date Cleared
2014-10-08
(140 days)
Product Code
HRX, GCJ
Regulation Number
888.1100Why 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
K082293Device Name
SURGVIEW INTEGRATED VISUALIZATION SYSTEM
Manufacturer
BIOVISION TECHNOLOGIES, LLC
Date Cleared
2008-09-09
(28 days)
Product Code
HRX, GCJ
Regulation Number
888.1100Why 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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