DeviceClearance

Product code OCU— Gastroenterology, Urology

Andorate Universal Endoscope Tip Guard

Classification name
Endoscopic Storage Cover
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

FDA classification definition

“To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.”

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

Market context for product code OCU

FDA has cleared 6 devices under product code OCU between 1994 and 2021, filed by 6 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 OCU

Recent clearances under product code OCU

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