K223376 is an FDA 510(k) clearance for the Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110). This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 21, 2023, 229 days after receiving the submission on November 4, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K223376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2022 |
| Decision Date | June 21, 2023 |
| Days to Decision | 229 days |
| Submission Type | Abbreviated |
| 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 |