510(k) K241442
K241442 is an FDA 510(k) premarket notification submitted by Epic Medical Pte. , Ltd. for the device "eZSURE Empty Fluid Container with ProSeal Injection Site". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Epic Medical Pte. , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2024
- Date Received
- May 22, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type