Cleared Traditional

NuVent EM Sinus Dilation System

K152121 · Medtronic Xomed, Inc. · Ear, Nose, Throat
Dec 2015
Decision
124d
Days
Class 1
Risk

About This 510(k) Submission

K152121 is an FDA 510(k) clearance for the NuVent EM Sinus Dilation System, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 1, 2015, 124 days after receiving the submission on July 30, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K152121 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2015
Decision Date December 01, 2015
Days to Decision 124 days
Submission Type Traditional
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

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