Clearance Summary
CLEWICU System received FDA 510(k) clearance under submission number K233216, sponsored by Clew Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-01-13.
- Submission: K233216
- Applicant / Sponsor: Clew Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2210
- Decision date: 2024-01-13
Classification & Regulation
This clearance is catalogued under FDA product code QNL and 21 CFR 870.2210, within the Cardiovascular review panel as a Class II device.