FDA Product Code ODG: Endoscopic Ultrasound System, Gastroenterology-urology

Endoscopic ultrasound combines the reach of endoscopy with the resolution of ultrasound. FDA product code ODG covers endoscopic ultrasound systems for gastroenterology and urology.

These devices integrate a miniaturized ultrasound transducer at the tip of an endoscope to provide real-time ultrasonic images of structures adjacent to the gastrointestinal wall — including the pancreas, bile ducts, lymph nodes, and submucosal lesions — that are not visible on standard endoscopy.

ODG devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Radiology panel.

Leading manufacturers include Pentax Precision Instrument Corp., Pentax of America, Inc. and Boston Scientific Corporation.