The FDA granted a 510(k) clearance to the SMART Medical Systems G-EYE Colonoscope for use in the U.S. market, based on the FDA-cleared PCF Colonoscope Series (Olympus), according to a press release.
The G-EYE Colonoscope can now be used in conjunction with the most commonly used colonoscope models from brands such as Fujifilm, Olympus and Pentax Medical.
By remanufacturing the already cleared colonoscopes to include a proprietary balloon at its distal bending section, SMART Medical has designed