DeviceClearance

Product code GZF— Neurology

StimRouter Neuromodulation System

Classification name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Device class
Class 2
Regulation
21 CFR 882.5870
Advisory panel
Neurology
Total cleared
25
First cleared
Most recent

Market context for product code GZF

FDA has cleared 25 devices under product code GZF between 1991 and 2026, filed by 11 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 GZF

Adverse events under product code GZF

product code GZF
Death
10
Injury
2,410
Other
1
Total
2,421

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 GZF

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