Cleared Special

ACCLARENT SE Inflation Device

K150172 · Acclarent, Inc. · Ear, Nose, Throat
Apr 2015
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K150172 is an FDA 510(k) clearance for the ACCLARENT SE Inflation Device, 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 7, 2015, 71 days after receiving the submission on January 26, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K150172 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2015
Decision Date April 07, 2015
Days to Decision 71 days
Submission Type Special
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