DeviceClearance

Product code JXI— Neurology

Axoguard HA+ Nerve Protector (5 models)

Classification name
Cuff, Nerve
Device class
Class 2
Regulation
21 CFR 882.5275
Advisory panel
Neurology
Total cleared
40
First cleared
Most recent

Market context for product code JXI

FDA has cleared 40 devices under product code JXI between 1985 and 2026, filed by 25 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 JXI

Recent clearances under product code JXI

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