K190183 is an FDA 510(k) clearance for the Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. (Taihu, Anqing City, CN). The FDA issued a Cleared decision on October 4, 2019, 245 days after receiving the submission on February 1, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K190183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 245 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 |