DeviceClearance

Product code GWF— Neurology

CAREFUSION NICOLET EDX

Classification name
Stimulator, Electrical, Evoked Response
Device class
Class 2
Regulation
21 CFR 882.1870
Advisory panel
Neurology
Total cleared
140
First cleared
Most recent

Market context for product code GWF

FDA has cleared 140 devices under product code GWF between 1978 and 2026, filed by 68 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 GWF

Adverse events under product code GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

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 GWF

1–100 of 140

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