K203738 is an FDA 510(k) clearance for the Qitexio. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medex (Saint-Priest, FR). The FDA issued a Cleared decision on March 14, 2022, 447 days after receiving the submission on December 22, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K203738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2020 |
| Decision Date | March 14, 2022 |
| Days to Decision | 447 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |