DeviceClearance

Product code GZB— Neurology

FIXATE TISSUE BAND

Classification name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class
Class 2
Regulation
21 CFR 882.5880
Advisory panel
Neurology
Total cleared
139
First cleared
Most recent

Market context for product code GZB

FDA has cleared 139 devices under product code GZB between 1978 and 2024, filed by 23 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 GZB

Adverse events under product code GZB

product code GZB
Death
4
Injury
1,879
Other
2
Total
1,885

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 GZB

1–100 of 139

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