Azure

Azure is a medical device manufactured by Daeshin Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2024-02-14 under approval number K231514. 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.