ODG · Class II · 21 CFR 876.1500

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 Boston Scientific Corporation, Fujifilm Corporation and Pentax of America, Inc..

42
Total
42
Cleared
99d
Avg days
1991
Since
Declining activity - 2 submissions in the last 2 years vs 5 in the prior period
Review times improving: avg 84d recently vs 99d historically

FDA 510(k) Cleared Endoscopic Ultrasound System, Gastroenterology-urology Devices (Product Code ODG)

42 devices
1–24 of 42
Cleared Oct 03, 2025
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
K251859
Olympus Medical Systems Corporation
Gastroenterology & Urology · 108d
Cleared Jul 18, 2025
InstaFAN
K251542
Onepass Medical , Ltd.
Gastroenterology & Urology · 59d
Cleared Mar 08, 2024
Ultrasonic Gastrovideoscope
K231813
Sonoscape Medical Corp.
Gastroenterology & Urology · 261d
Cleared Dec 27, 2023
EndoSound Vision System
K232518
Endosound, Inc.
Gastroenterology & Urology · 131d
Cleared Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K223616
Boston Scientific Corporation
Gastroenterology & Urology · 25d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 04, 2022
Endoscope Model EG-580UT and Endoscope Model EG-580UR
K221952
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089
Fujifilm Corporation
Radiology · 157d
Cleared Dec 06, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle
K212852
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K203166
Pentax of America, Inc.
Gastroenterology & Urology · 68d
Cleared Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
K200090
Pentax of America, Inc.
Gastroenterology & Urology · 189d
Cleared Sep 05, 2019
FUJIFILM Ultrasonic Endoscope
K183433
Fujifilm Corporation
Gastroenterology & Urology · 268d
Cleared Aug 21, 2018
PENTAX Medical Endoscopic Ultrasound System
K182004
Pentax of America, Inc.
Gastroenterology & Urology · 25d
Cleared Apr 19, 2018
Ultramatrix EUS Balloon
K180731
United States Endoscopy Group, Inc. (Us Endoscopy)
Gastroenterology & Urology · 30d
Cleared Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 261d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845
Boston Scientific Corporation
Gastroenterology & Urology · 36d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Jan 12, 2011
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
K110030
Boston Scientific Corp
Gastroenterology & Urology · 7d

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 5 in the prior period.

FDA 510(k) Review Time - ODG Product Code

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 →