DeviceClearance

Product code ODC— Gastroenterology, Urology

DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)

Classification name
Endoscope Channel Accessory
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
72
First cleared
Most recent

FDA classification definition

“To give the endoscope channel additional or improved functionality.”

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

Market context for product code ODC

FDA has cleared 72 devices under product code ODC between 1980 and 2026, filed by 50 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 ODC

Recent clearances under product code ODC

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