Clearance Summary
ProSeal Transfer Injector (421120, 421130, 421140) received FDA 510(k) clearance under submission number K251722, 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 2025-12-05.
- Submission: K251722
- 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: 2025-12-05
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.