Cleared Traditional

ILLUMINATING SINUS SEEKER

K110158 · Entellus Medical, Inc. · Ear, Nose, Throat
Jun 2011
Decision
139d
Days
Class 1
Risk

About This 510(k) Submission

K110158 is an FDA 510(k) clearance for the ILLUMINATING SINUS SEEKER, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 7, 2011, 139 days after receiving the submission on January 19, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K110158 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2011
Decision Date June 07, 2011
Days to Decision 139 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420