Clearance Summary
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System received FDA 510(k) clearance under submission number K230065, sponsored by Fiagon GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2023-05-26.
- Submission: K230065
- Applicant / Sponsor: Fiagon GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4180
- Decision date: 2023-05-26
Classification & Regulation
This clearance is catalogued under FDA product code PNZ and 21 CFR 874.4180, within the Ear, Nose, Throat review panel as a Class II device.