K140949 is an FDA 510(k) clearance for the ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Ultimed Incorporated (Minneapolis, US). The FDA issued a Cleared decision on February 9, 2015, 301 days after receiving the submission on April 14, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K140949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2014 |
| Decision Date | February 09, 2015 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |