K173881 is an FDA 510(k) clearance for the Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G. 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 July 11, 2018, 202 days after receiving the submission on December 21, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K173881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2017 |
| Decision Date | July 11, 2018 |
| Days to Decision | 202 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 |