Cleared Traditional

K161697 - Acclarent NavWire Sinus Navigation Guidewire

K161697 is an FDA 510(k) clearance for Acclarent NavWire Sinus Navigation Guid..., manufactured by Acclarent, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K161697 · Acclarent, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 2016
Decision
126d
Days
Class 2
Risk

K161697 is an FDA 510(k) clearance for the Acclarent NavWire Sinus Navigation Guidewire. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on October 24, 2016 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Acclarent, Inc. devices

FDA 510(k) Submission Details - K161697

510(k) Number K161697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 90d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGW Device Classification - Class 2, Special Controls

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 33
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K161697.
StealthStationTM S8 ENT Software
K170018 · Medtronic Navigation, Inc. · May 2017
Fiagon Navigation – PointerTube Straight and PointerTube Keat
K163416 · Fiagon GmbH · Feb 2017
Fiagon Navigation System
K162176 · Fiagon GmbH · Dec 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · KARL STORZ Endoscopy-America, Inc. · Oct 2016
Guidewire 0.6 Single Use
K161940 · Fiagon GmbH · Sep 2016
EM ENT Navigated Suctions
K153555 · Medtronic Navigation, Inc. · Apr 2016