K103011 is an FDA 510(k) clearance for the ULTICARE SAFETY INSULIN SYRINGE. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Ulti-Med Intl., Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 2, 2011, 113 days after receiving the submission on October 12, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K103011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2010 |
| Decision Date | February 02, 2011 |
| Days to Decision | 113 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 |