Cleared Special

RELIEVA SCOUT SINUS DILATION SYSTEM

K140160 · Acclarent, Inc. · Ear, Nose, Throat
Feb 2014
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K140160 is an FDA 510(k) clearance for the RELIEVA SCOUT SINUS DILATION SYSTEM, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on February 20, 2014, 29 days after receiving the submission on January 22, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K140160 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2014
Decision Date February 20, 2014
Days to Decision 29 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