DeviceClearance

Product code KBF— Ear, Nose, Throat

MONTG. TRACHEAL TREPHINE FENE STRATOR

Classification name
Trephine, Sinus
Device class
Class 1
Regulation
21 CFR 874.4420
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

Market context for product code KBF

FDA has cleared 1 device under product code KBF, all in 1980, 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 KBF

Recent clearances under product code KBF

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