Cleared Traditional

SINUFLUSH LAVAGE SYSTEM

K131177 · Hedgepath, LLC · Ear, Nose, Throat
Sep 2013
Decision
148d
Days
Class 1
Risk

About This 510(k) Submission

K131177 is an FDA 510(k) clearance for the SINUFLUSH LAVAGE SYSTEM, a Irrigator, Sinus (Class I — General Controls, product code KAR), submitted by Hedgepath, LLC (Tampa, US). The FDA issued a Cleared decision on September 20, 2013, 148 days after receiving the submission on April 25, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K131177 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2013
Decision Date September 20, 2013
Days to Decision 148 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KAR — Irrigator, Sinus
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420