Cleared Special

XPRESS MULTI-SINUS DILATION TOOL

K121174 · Entellus Medical, Inc. · Ear, Nose, Throat
May 2012
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K121174 is an FDA 510(k) clearance for the XPRESS MULTI-SINUS DILATION TOOL, 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 May 17, 2012, 30 days after receiving the submission on April 17, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K121174 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2012
Decision Date May 17, 2012
Days to Decision 30 days
Submission Type Special
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