Device type

Endoscopic Ultrasound System, Gastroenterology-Urology

Product code ODG · Class II · 21 CFR 876.1500 · Gastroenterology, Urology

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).

FDA classification database