Cleared Traditional

Relieva SpinPlus Nav Balloon Sinuplasty System

K171687 · Acclarent, Inc. · Ear, Nose, Throat
Sep 2017
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K171687 is an FDA 510(k) clearance for the Relieva SpinPlus Nav Balloon Sinuplasty System, 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 September 5, 2017, 90 days after receiving the submission on June 7, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K171687 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2017
Decision Date September 05, 2017
Days to Decision 90 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