Clearance Summary
UNEEG EpiSight System received FDA 510(k) clearance under submission number K253607, sponsored by Uneeg Medical A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-06-11.
- Submission: K253607
- Applicant / Sponsor: Uneeg Medical A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1360
- Decision date: 2026-06-11
Classification & Regulation
This clearance is catalogued under FDA product code SEM and 21 CFR 882.1360, within the Neurology review panel as a Class II device.