K241442 is an FDA 510(k) clearance for the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on June 21, 2024, 30 days after receiving the submission on May 22, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K241442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2024 |
| Decision Date | June 21, 2024 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE — Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |