Clearance Summary
ProSeal Injection Site Extended Male Luer Lock (422140) received FDA 510(k) clearance under submission number K240433, 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 2024-05-21.
- Submission: K240433
- Applicant / Sponsor: Epic Medical Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2024-05-21
Classification & Regulation
This clearance is catalogued under FDA product code ONB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.