K230235 is an FDA 510(k) clearance for the Medline Luer Lock Syringes. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on February 16, 2024, 385 days after receiving the submission on January 27, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K230235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2023 |
| Decision Date | February 16, 2024 |
| Days to Decision | 385 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 |