Product code KAR— Ear, Nose, Throat

FISCH DRILL IRRIGATOR

Classification name
Irrigator, Sinus
Device class
Class 1
Regulation
21 CFR 874.4420
Advisory panel
Ear, Nose, Throat
Total cleared
3
First cleared
Most recent

Market context for product code KAR

FDA has cleared 3 devices under product code KAR between 1986 and 2013, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code KAR

Recent clearances under product code KAR

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