Clearance Summary
eZSURE Empty Fluid Container (models 426030, 426040, 426110) received FDA 510(k) clearance under submission number K223674, sponsored by Epic Medical Pte. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-09-01.
- Submission: K223674
- Applicant / Sponsor: Epic Medical Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 2023-09-01
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.