Clearance Summary
ProSeal Bag Spike with Additive Port (423370ST, 423370) received FDA 510(k) clearance under submission number K251340, sponsored by Epic Medical Pte. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-05-29.
- Submission: K251340
- Applicant / Sponsor: Epic Medical Pte. , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2025-05-29
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.