K223674 is an FDA 510(k) clearance for the eZSURE™ Empty Fluid Container (models 426030, 426040, 426110). 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 September 1, 2023, 268 days after receiving the submission on December 7, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K223674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2022 |
| Decision Date | September 01, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| 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 |