K160887 is an FDA 510(k) clearance for the Cook Intraosseous Infusion Needles. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 26, 2016, 117 days after receiving the submission on March 31, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K160887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2016 |
| Decision Date | July 26, 2016 |
| Days to Decision | 117 days |
| Submission Type | Special |
| 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 |