Cleared Special

XPRESS MULTI-SINUS DILATION TOOL

K132440 · Entellus Medical, Inc. · Ear, Nose, Throat
Oct 2013
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K132440 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. (Plymouth, US). The FDA issued a Cleared decision on October 4, 2013, 59 days after receiving the submission on August 6, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K132440 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2013
Decision Date October 04, 2013
Days to Decision 59 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