Cleared Traditional

RELIEVA SPIN SINUS DILATION SYSTEM

K111875 · Acclarent, Inc. · Ear, Nose, Throat
Oct 2011
Decision
102d
Days
Class 1
Risk

About This 510(k) Submission

K111875 is an FDA 510(k) clearance for the RELIEVA SPIN 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 October 11, 2011, 102 days after receiving the submission on July 1, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K111875 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2011
Decision Date October 11, 2011
Days to Decision 102 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