ODG

Endoscopic Ultrasound System, Gastroenterology-Urology

Product code

ODG

Device name

Endoscopic Ultrasound System, Gastroenterology-Urology

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

6

Summaries archived here

6 (direct download)

510(k) clearances (all years, FDA)

44 (all years; only the last 3 years are listed here)

FDA classification definition

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-07-31.

6 summaries are archived here for direct download.