K183665 is an FDA 510(k) clearance for the Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Jiangsu Micsafe Medical Technology Co., Ltd. (Yancheng, CN). The FDA issued a Cleared decision on September 6, 2019, 253 days after receiving the submission on December 27, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K183665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2018 |
| Decision Date | September 06, 2019 |
| Days to Decision | 253 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 |