Cleared Special

K261540 - Cube 4D Navigation System, VirtuEye Pro

K261540 is an FDA 510(k) clearance for Cube 4D Navigation System, manufactured by Fiagon GmbH. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Special 510(k) pathway after a 25-day FDA review.

K261540 · Fiagon GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
25d
Days
Class 2
Risk

K261540 is an FDA 510(k) clearance for the Cube 4D Navigation System, VirtuEye Pro. 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 June 2, 2026 after a review of 25 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K261540

510(k) Number K261540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2026
Decision Date June 02, 2026
Days to Decision 25 days
Submission Type Special
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
65d faster than avg
Panel avg: 90d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K261540.
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM)
K262235 · Medtronic Xomed, Inc. · Sep 2026
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
K261540 · Cube 4D Navigation System, VirtuEye Pro
Download PDF FDA Summary Fiagon GmbH