FDA 510(k)

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

K-Number: K211291 · 2021-07-19

Decision Date2021-07-19

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2021-07-19 under approval number K211291. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by Fiagon GmbH. The 510(k) number is K211291.

When was Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D approved by the FDA?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D received FDA 510(k) clearance on 2021-07-19, under approval number K211291.

What company makes Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is manufactured by Fiagon GmbH.

What is the FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D?

The FDA product code for Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D is PGW.

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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Fiagon GmbH

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Related Devices (Code: PGW)

K162176Fiagon Navigation SystemFiagon GmbH K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. K161701CARTO ENT SystemBiosense Webster K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc. K161940Guidewire 0.6 Single UseFiagon GmbH K153555EM ENT Navigated SuctionsMedtronic Navigation, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.