K230065 is an FDA 510(k) clearance for the VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System. This device is classified as a Eustachian Tube Balloon Dilation Device (Class II - Special Controls, product code PNZ).
Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on May 26, 2023, 137 days after receiving the submission on January 9, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4180. The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction..
| 510(k) Number | K230065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2023 |
| Decision Date | May 26, 2023 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | PNZ - Eustachian Tube Balloon Dilation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4180 |
| Definition | The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction. |