DeviceClearance

Product code GXD— Neurology

APEX 6

Classification name
Generator, Lesion, Radiofrequency
Device class
Class 2
Regulation
21 CFR 882.4400
Advisory panel
Neurology
Total cleared
37
First cleared
Most recent

Market context for product code GXD

FDA has cleared 37 devices under product code GXD between 1991 and 2025, filed by 27 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 GXD

Adverse events under product code GXD

product code GXD
Injury
228
Total
228

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GXD

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