DeviceClearance

Product code GZI— Neurology

L300 Go System

Classification name
Stimulator, Neuromuscular, External Functional
Device class
Class 2
Regulation
21 CFR 882.5810
Advisory panel
Neurology
Total cleared
61
First cleared
Most recent

Market context for product code GZI

FDA has cleared 61 devices under product code GZI between 1977 and 2025, filed by 30 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 GZI

Recent clearances under product code GZI

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