KAR · Class I · 21 CFR 874.4420

FDA Product Code KAR: Irrigator, Sinus

Leading manufacturers include Hedgepath, LLC and Jedmed Instrument Co..

3
Total
3
Cleared
109d
Avg days
1986
Since

FDA 510(k) Cleared Irrigator, Sinus Devices (Product Code KAR)

3 devices
1–3 of 3
Cleared Sep 20, 2013
SINUFLUSH LAVAGE SYSTEM
K131177
Hedgepath, LLC
Ear, Nose, Throat · 148d
Cleared Apr 23, 1986
FISCH DRILL IRRIGATOR
K861298
Jedmed Instrument Co.
Ear, Nose, Throat · 16d

About Product Code KAR - Regulatory Context