Clearance Summary
Sunrise received FDA 510(k) clearance under submission number K250874, sponsored by Sunrise SA. 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 2025-08-29.
- Submission: K250874
- Applicant / Sponsor: Sunrise SA
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 868.2376
- Decision date: 2025-08-29
Classification & Regulation
This clearance is catalogued under FDA product code QRS and 21 CFR 868.2376, within the Ear, Nose, Throat review panel as a Class II device.