OmniGuide BeamPath OTO-U Fiber

OmniGuide BeamPath OTO-U Fiber is a medical device manufactured by Omniguide, Inc.. It received FDA 510(k) clearance on 2021-01-14 under approval number K203241. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.