DeviceClearance

Product code GWM— Neurology

CMA CEREBRAL TISSUE MONITORING SYSTEM

Classification name
Device, Monitoring, Intracranial Pressure
Device class
Class 2
Regulation
21 CFR 882.1620
Advisory panel
Neurology
Total cleared
105
First cleared
Most recent

Market context for product code GWM

FDA has cleared 105 devices under product code GWM between 1978 and 2026, filed by 45 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 GWM

Adverse events under product code GWM

product code GWM
Death
21
Injury
732
Malfunction
2,063
Other
1
Total
2,817

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 GWM

1–100 of 105

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