Cleared Traditional

Relieva SpinPlus Balloon Sinuplasty System

K143541 · Acclarent, Inc. · Ear, Nose, Throat
Apr 2015
Decision
128d
Days
Class 1
Risk

About This 510(k) Submission

K143541 is an FDA 510(k) clearance for the Relieva SpinPlus Balloon Sinuplasty 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 April 22, 2015, 128 days after receiving the submission on December 15, 2014. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K143541 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2014
Decision Date April 22, 2015
Days to Decision 128 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