K241821 is an FDA 510(k) clearance for the Luer Lock Syringe with Safety Needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Sol-Millennium Medical, Inc. (Chicago, US). The FDA issued a Cleared decision on September 20, 2024, 88 days after receiving the submission on June 24, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K241821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2024 |
| Decision Date | September 20, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| 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 |