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 Fujifilm Corporation, Micro-Tech (Nanjing) Co., Ltd. and Boston Scientific Corporation.
FDA 510(k) Cleared Endoscopic Ultrasound System, Gastroenterology-urology Devices (Product Code ODG)
About Product Code ODG - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code ODG since 1991, with 42 receiving FDA clearance (average review time: 99 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under ODG have taken an average of 84 days to reach a decision - down from 99 days historically, suggesting improved FDA processing for this classification.
ODG devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →