Sinuflush Lavage System

FDA 510(k) K131177 · Hedgepath, LLC

Substantially Equivalent

510(k) numberK131177

Submission

Device name
Sinuflush Lavage System
Applicant
Hedgepath, LLC
Tampa, FL, US
Received
April 25, 2013
Decision date
September 20, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KAR – Irrigator, Sinus
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KAR

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

Questions and answers

When was Sinuflush Lavage System cleared by the FDA?

Sinuflush Lavage System (K131177) received a 510(k) decision of Substantially Equivalent on September 20, 2013, 148 days after the submission was received.

What is the product code of K131177?

The FDA product code is KAR – Irrigator, Sinus, a Class I (low risk) device regulated under 21 CFR 874.4420.