K211291 is an FDA 510(k) clearance for the Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D. This device is classified as 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 FDA review panel. Regulated under 21 CFR 882.4560. 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..
| 510(k) Number | K211291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |