K233056 is an FDA 510(k) clearance for the EpiZact. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Guidestar Medical Devices (Victoria, CA). The FDA issued a Cleared decision on November 2, 2023, 38 days after receiving the submission on September 25, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K233056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |