DeviceClearance

Product code ETN— Ear, Nose, Throat

NUVASIVE NEUROVISION JJB SYSTEM

Classification name
Stimulator, Nerve
Device class
Class 2
Regulation
21 CFR 874.1820
Advisory panel
Ear, Nose, Throat
Total cleared
97
First cleared
Most recent

Market context for product code ETN

FDA has cleared 97 devices under product code ETN between 1978 and 2026, filed by 51 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 ETN

Adverse events under product code ETN

product code ETN
Death
7
Injury
327
Malfunction
2,776
Total
3,110

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 ETN

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