Cleared Special

K162176 - Fiagon Navigation System (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162176 · Fiagon GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
120d
Days
Class 2
Risk

K162176 is an FDA 510(k) clearance for the Fiagon Navigation System. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on December 1, 2016 after a review of 120 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fiagon GmbH devices

Submission Details

510(k) Number K162176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2016
Decision Date December 01, 2016
Days to Decision 120 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 89d · This submission: 120d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 35
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K162176.
Stealth AXiS™ ENT clinical application
K253395 · Medtronic Navigation, Inc. · Mar 2026
Navient Image Guided Navigation System (ENT) (955-NC-NC)
K243053 · Claronav · Jun 2025
TruDi® Navigation System V3 (FG-2000-00)
K231862 · Acclarent, Inc. · Jul 2023
ENT EM
K223734 · Brainlab AG · Apr 2023
TruDi Shaver Blade
K221037 · Acclarent, Inc. · Jul 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
K221098 · Stryker Corporation · Jul 2022