510(k) K230065
K230065 is an FDA 510(k) premarket notification submitted by Fiagon GmbH for the device "VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code PNZ (Eustachian Tube Balloon Dilation Device), a Class II device regulated under 21 CFR 874.4180. Fiagon GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2023
- Date Received
- January 9, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eustachian Tube Balloon Dilation Device
- Device Class
- Class II
- Regulation Number
- 874.4180
- Review Panel
- EN
- Submission Type
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.