K221981 is an FDA 510(k) clearance for the SafeR Syringe and SafeR Sting. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Roncadelle Operations Srl (Castel Mella (Brescia), IT). The FDA issued a Cleared decision on December 29, 2022, 177 days after receiving the submission on July 5, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K221981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | December 29, 2022 |
| Days to Decision | 177 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 |