Cleared Special

XPRESS MULTI-SINUS DILATION TOOL

K121943 · Entellus Medical, Inc. · Ear, Nose, Throat
Aug 2012
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K121943 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 August 22, 2012, 50 days after receiving the submission on July 3, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K121943 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2012
Decision Date August 22, 2012
Days to Decision 50 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