DeviceClearance

Product code GWN— Neurology

VisualEyes

Classification name
Nystagmograph
Device class
Class 2
Regulation
21 CFR 882.1460
Advisory panel
Neurology
Total cleared
60
First cleared
Most recent

Market context for product code GWN

FDA has cleared 60 devices under product code GWN between 1981 and 2026, filed by 44 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 GWN

Recent clearances under product code GWN

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