Product code OCV— Gastroenterology, Urology

CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)

Classification name
Endoscope Holder
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
10
First cleared
Most recent

FDA classification definition

“To hold endoscope in a desired position during procedures.”

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

Market context for product code OCV

FDA has cleared 10 devices under product code OCV between 1981 and 2024, filed by 8 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

Top applicants under product code OCV

Recent clearances under product code OCV

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