K202570 is an FDA 510(k) clearance for the Insulin Syringe, Insulin Syringe with Safety Retractable. 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 July 2, 2021, 301 days after receiving the submission on September 4, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K202570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2020 |
| Decision Date | July 02, 2021 |
| Days to Decision | 301 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 |