K162030 is an FDA 510(k) clearance for the 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on August 19, 2016, 28 days after receiving the submission on July 22, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K162030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2016 |
| Decision Date | August 19, 2016 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |