Clearance Summary
TubaVent Balloon Dilatation System received FDA 510(k) clearance under submission number K223542, sponsored by Spiggle & Theis Medizintechnik 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 2023-08-03.
- Submission: K223542
- Applicant / Sponsor: Spiggle & Theis Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4180
- Decision date: 2023-08-03
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.