Clearance Summary
Quadsense (Quadsense and Quadsense Pro) received FDA 510(k) clearance under submission number K252524, sponsored by Eventum Orthopaedics, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-09-09.
- Submission: K252524
- Applicant / Sponsor: Eventum Orthopaedics, Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-09-09
Classification & Regulation
This clearance is catalogued under FDA product code ONN and 21 CFR 882.4560, within the Neurology review panel as a Class II device.