K231558 is an FDA 510(k) clearance for the SMB Luer lock disposable syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Smb Corporation of India (Valsad, IN). The FDA issued a Cleared decision on January 12, 2024, 227 days after receiving the submission on May 30, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K231558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2023 |
| Decision Date | January 12, 2024 |
| Days to Decision | 227 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 |