Cleared Traditional

Relieva Scout Multi-Sinus Dilation System

K153341 · Acclarent, Inc. · Ear, Nose, Throat
Feb 2016
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K153341 is an FDA 510(k) clearance for the Relieva Scout Multi-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 12, 2016, 85 days after receiving the submission on November 19, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K153341 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2015
Decision Date February 12, 2016
Days to Decision 85 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