K172670 is an FDA 510(k) clearance for the BD Single Use, Hypodermic 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 October 23, 2018, 413 days after receiving the submission on September 5, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K172670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2017 |
| Decision Date | October 23, 2018 |
| Days to Decision | 413 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 |