DeviceClearance

Product code GWY— Neurology

1-380 PINWHEEL (WARTENBERG)

Classification name
Pinwheel
Device class
Class 1
Regulation
21 CFR 882.1750
Advisory panel
Neurology
Total cleared
5
First cleared
Most recent

Market context for product code GWY

FDA has cleared 5 devices under product code GWY between 1978 and 2005, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code GWY

Recent clearances under product code GWY

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