Cleared Special

Acclarent ENT Navigation System

K173628 · Acclarent, Inc. · Ear, Nose, Throat

Mar 2018

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K173628 is an FDA 510(k) clearance for the Acclarent ENT Navigation System, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Acclarent, Inc. (Menlo Park, US). The FDA issued a Cleared decision on March 10, 2018, 106 days after receiving the submission on November 24, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K173628 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2017
Decision Date	March 10, 2018
Days to Decision	106 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.