DeviceClearance

Product code ODG— Gastroenterology, Urology

EG-3670URK

Classification name
Endoscopic Ultrasound System, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
44
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code ODG under 21 CFR 876.1500, via openFDA

Market context for product code ODG

FDA has cleared 44 devices under product code ODG between 1991 and 2026, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ODG

Adverse events under product code ODG

product code ODG
Death
30
Injury
237
Malfunction
12,387
Other
1
Total
12,655

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ODG

Data sourced from openFDA. This site is unofficial and independent of the FDA.