Cleared Special

XprESS Multi-Sinus Dilation Tool

K142252 · Entellus Medical, Inc. · Ear, Nose, Throat
Oct 2014
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K142252 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 17, 2014, 64 days after receiving the submission on August 14, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K142252 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2014
Decision Date October 17, 2014
Days to Decision 64 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