Cleared Traditional

Next Generation Balloon Dilation System

K201115 · Acclarent, Inc. · Ear, Nose, Throat
Aug 2020
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K201115 is an FDA 510(k) clearance for the Next Generation Balloon Dilation System, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on August 27, 2020, 122 days after receiving the submission on April 27, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K201115 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date August 27, 2020
Days to Decision 122 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