K203359 is an FDA 510(k) clearance for the BD Flu+ Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 28, 2021, 254 days after receiving the submission on November 16, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K203359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2020 |
| Decision Date | July 28, 2021 |
| Days to Decision | 254 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 |