K192421 is an FDA 510(k) clearance for the EpiFaith Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Flat Medical Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on September 27, 2019, 23 days after receiving the submission on September 4, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K192421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | September 27, 2019 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |