K243660 is an FDA 510(k) clearance for the Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on August 22, 2025, 268 days after receiving the submission on November 27, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K243660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2024 |
| Decision Date | August 22, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |