K193022 is an FDA 510(k) clearance for the Retractable Safety Insulin Syringe. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on July 20, 2020, 264 days after receiving the submission on October 30, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K193022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2019 |
| Decision Date | July 20, 2020 |
| Days to Decision | 264 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 |