Irrigator, Sinus

FDA product code KAR · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K131177Sinuflush Lavage SystemKAR · Traditional Hedgepath, LLC09/20/2013SE
K931398GM Swivel Video (TM) IrrigatorKAR · Traditional Gm Engineering, Inc.08/30/1993SE
K861298Fisch Drill IrrigatorKAR · Traditional Jedmed Instrument Co.04/23/1986SE