K222744 is an FDA 510(k) clearance for the Sol-M Luer Lock Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Sol-Millennium Medical, Inc. (Suwanee, US). The FDA issued a Cleared decision on October 11, 2022, 29 days after receiving the submission on September 12, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K222744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2022 |
| Decision Date | October 11, 2022 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |