ELEMENT-TL

ELEMENT-TL is a medical device manufactured by Elemenic Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under approval number K180224. 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.