Clearance Summary
Sinusway Dilation System received FDA 510(k) clearance under submission number K181838, sponsored by 3nt Medical , Ltd.. 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 2018-12-20.
- Submission: K181838
- Applicant / Sponsor: 3nt Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2018-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.