DeviceClearance

Product code ODD— Gastroenterology, Urology

ERCP CANNULA

Classification name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
18
First cleared
Most recent

FDA classification definition

“To identify stones, tumors, or narrowing in the biliary tree.”

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

Market context for product code ODD

FDA has cleared 18 devices under product code ODD between 1980 and 2025, filed by 15 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 ODD

Recent clearances under product code ODD

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