Cleared Traditional

Acclarent NavWire Sinus Navigation Guidewire

K161697 · Acclarent, Inc. · Ear, Nose, Throat

Oct 2016

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K161697 is an FDA 510(k) clearance for the Acclarent NavWire Sinus Navigation Guidewire, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on October 24, 2016, 126 days after receiving the submission on June 20, 2016. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K161697 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2016
Decision Date	October 24, 2016
Days to Decision	126 days
Submission Type	Traditional
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.