K210216 is an FDA 510(k) clearance for the Disposable Automatically Retractable Insulin Safety Syringe. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Shantou Wealy Medical Instrument Co.,Ltd (Shantou, CN). The FDA issued a Cleared decision on March 4, 2022, 401 days after receiving the submission on January 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K210216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2021 |
| Decision Date | March 04, 2022 |
| Days to Decision | 401 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 |