K231924 is an FDA 510(k) clearance for the EZ-IO Intraosseous Vascular Access System. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on July 25, 2023, 25 days after receiving the submission on June 30, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K231924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2023 |
| Decision Date | July 25, 2023 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |