Product code GXE— Neurology

DISPOSABLE MONOPLAR MEDDLE ELECTRODES

Classification name
Leukotome
Device class
Class 1
Regulation
21 CFR 882.4600
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

Market context for product code GXE

FDA has cleared 1 device under product code GXE, all in 1992, filed by 1 applicant company. 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.

Top applicants under product code GXE

Recent clearances under product code GXE

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