K160190 is an FDA 510(k) clearance for the Sunmed Control Syringes. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Sunny Medical Device (Shenzhen) Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on November 10, 2016, 288 days after receiving the submission on January 27, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K160190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2016 |
| Decision Date | November 10, 2016 |
| Days to Decision | 288 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXT - Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |