DeviceClearance

Product code GXH— Neurology

iovera system

Classification name
Device, Surgical, Cryogenic
Device class
Class 2
Regulation
21 CFR 882.4250
Advisory panel
Neurology
Total cleared
23
First cleared
Most recent

Market context for product code GXH

FDA has cleared 23 devices under product code GXH between 1978 and 2025, filed by 8 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 GXH

Recent clearances under product code GXH

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