Cleared Traditional

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D

K211291 · Fiagon GmbH · Ear, Nose, Throat

Jul 2021

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K211291 is an FDA 510(k) clearance for the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on July 19, 2021, 82 days after receiving the submission on April 28, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K211291 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2021
Decision Date	July 19, 2021
Days to Decision	82 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.