DeviceClearance

Product code HAW— Neurology

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

Classification name
Neurological Stereotaxic Instrument
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
424
First cleared
Most recent

Market context for product code HAW

FDA has cleared 424 devices under product code HAW between 1979 and 2026, filed by 151 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 HAW

Adverse events under product code HAW

product code HAW
Death
52
Injury
1,083
Malfunction
17,300
Total
18,435

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 HAW

1–100 of 424

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