DeviceClearance

Product code KBI— Ear, Nose, Throat

BOUGIE, FILIFORM, JACKSON

Classification name
Bougie, Eustachian
Device class
Class 1
Regulation
21 CFR 874.4175
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

Market context for product code KBI

FDA has cleared 1 device under product code KBI, all in 1977, 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 KBI

Recent clearances under product code KBI

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