Cleared Traditional

NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER

K140542 · Rhinosystems, Inc. · Ear, Nose, Throat

Jun 2014

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K140542 is an FDA 510(k) clearance for the NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER, a Irrigator, Powered Nasal (Class I — General Controls, product code KMA), submitted by Rhinosystems, Inc. (Brooklyn Heights, US). The FDA issued a Cleared decision on June 27, 2014, 115 days after receiving the submission on March 4, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5550.

Submission Details

510(k) Number	K140542 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2014
Decision Date	June 27, 2014
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF