Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
FDA 510(k) K211291 · Fiagon GmbH
510(k) numberK211291
Submission
- Device name
- Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- Applicant
- Fiagon GmbH
Hennigsdorf, DE - Received
- April 28, 2021
- Decision date
- July 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGW – Ear, Nose, And Throat Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
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.
Other 510(k)s with product code PGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | Medtronic Xomed, Inc. | 09/04/2026SE |
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | Fiagon GmbH | 06/02/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | Medtronic Navigation, Inc. | 03/16/2026SE |
| K243053 | Navient Image Guided Navigation System (ENT) (955-NC-NC)PGW · Traditional | Claronav | 06/20/2025SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | Acclarent, Inc. | 07/21/2023SE |
| K223734 | ENT EmPGW · Traditional | Brainlab AG | 04/27/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | Acclarent, Inc. | 07/20/2022SE |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…PGW · Traditional | Stryker Corporation | 07/12/2022SE |
| K202609 | Instrument Clamps ElectromagneticPGW · Special | Stryker Corporation | 10/09/2020SE |
| K201174 | TruDi CurettePGW · Traditional | Acclarent, Inc. | 08/12/2020SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | 06/02/2026SE |
| K230700 | RIWOtrack Navigation SystemOLO · Traditional | 11/20/2023SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | 05/26/2023SE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceLRC · Traditional | 08/26/2020SE |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW · Special | 03/10/2020SE |
| K163209 | Fiagon Navigation SystemHAW · Traditional | 09/14/2017SE |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube KeatPGW · Special | 02/16/2017SE |
| K162176 | Fiagon Navigation SystemPGW · Special | 12/01/2016SE |
| K161940 | Guidewire 0.6 Single UsePGW · Special | 09/18/2016SE |
| K151156 | Fiagon Navigation SystemHAW · Traditional | 04/01/2016SE |
Questions and answers
When was Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D cleared by the FDA?
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D (K211291) received a 510(k) decision of Substantially Equivalent on July 19, 2021, 82 days after the submission was received.
What is the product code of K211291?
The FDA product code is PGW – Ear, Nose, And Throat Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.