K152339 is an FDA 510(k) clearance for the Unifine Pentips/ Unifine Pentips Plus. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on June 24, 2016, 310 days after receiving the submission on August 19, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K152339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2015 |
| Decision Date | June 24, 2016 |
| Days to Decision | 310 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 |