K242434 is an FDA 510(k) clearance for the Insulin Syringes. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Chirana T. Injecta (Stará Turá, SK). The FDA issued a Cleared decision on December 24, 2024, 130 days after receiving the submission on August 16, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K242434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2024 |
| Decision Date | December 24, 2024 |
| Days to Decision | 130 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 |