FDA Clears Smart Medical G-Eye Colonoscope

FDA has cleared a Smart Medical Systems 510(k) for the G-Eye Colonoscope. The device is a standard colonoscope which Smart remanufactures by installing its proprietary G-Eye balloon on the distal bending section of the colonoscope. During colonoscopy, the G-Eye colonoscope is inserted in the standard technique, with the balloon deflated, the company says. Once the colon is intubated and prior to withdrawal, the balloon is inflated to engage the colon lumen. Withdrawal of the device through the colon with the balloon moderately inflated “centralizes the image of the colon lumen, flattens colonic folds, and reduces the amount of bowel slippage, thereby assisting in controlling the colonoscope’s field of view and positioning,” it says. Under the 510(k), the G-Eye will be available on the Olympus (eight models) and Pentax Medical (three models). Smart says it is currently preparing a 510(k) submission for the Fujifilm brand.