K140568 is an FDA 510(k) clearance for the CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Facet Technologies, LLC (Kennesaw, US). The FDA issued a Cleared decision on May 13, 2014, 69 days after receiving the submission on March 5, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K140568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2014 |
| Decision Date | May 13, 2014 |
| Days to Decision | 69 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 |