K170824 is an FDA 510(k) clearance for the BD Vacutainer Eclipse Signal Blood Collection Needle. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on August 20, 2018, 518 days after receiving the submission on March 20, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K170824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2017 |
| Decision Date | August 20, 2018 |
| Days to Decision | 518 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |