Cleared Traditional

Relieva UltirraNav Sinus Balloon Catheter

K161698 · Acclarent, Inc. · Ear, Nose, Throat
Oct 2016
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K161698 is an FDA 510(k) clearance for the Relieva UltirraNav Sinus Balloon Catheter, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on October 24, 2016, 126 days after receiving the submission on June 20, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K161698 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2016
Decision Date October 24, 2016
Days to Decision 126 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