Cleared Special

XPRESS MULTI-SINUS DILATION TOOL

K112506 · Entellus Medical, Inc. · Ear, Nose, Throat
Dec 2011
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K112506 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 December 21, 2011, 113 days after receiving the submission on August 30, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K112506 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2011
Decision Date December 21, 2011
Days to Decision 113 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