DeviceClearance

Product code QJL— Ear, Nose, Throat

SinuBand

Classification name
Splint, Intranasal Septal, Cber Led
Device class
Class 1
Regulation
21 CFR 874.4780
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

FDA classification definition

“Splint, Intranasal Septal, CBER led”

— U.S. Food and Drug Administration, device classification record for product code QJL under 21 CFR 874.4780, via openFDA

Market context for product code QJL

FDA has cleared 1 device under product code QJL, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QJL

Recent clearances under product code QJL

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