DeviceClearance

Product code OCT— Gastroenterology, Urology

AMD Anti-Fog Solution

Classification name
Anti Fog Solution And Accessories, Endoscopy
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
27
First cleared
Most recent

FDA classification definition

“To prevent, reduce or eliminate condensation (fog) on endoscopic lens.”

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

Market context for product code OCT

FDA has cleared 27 devices under product code OCT between 1991 and 2025, filed by 26 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 OCT

Recent clearances under product code OCT

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