K233794 is an FDA 510(k) clearance for the Insulin Syringe. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Spm Medicare Pvt. , Ltd. (Noida, IN). The FDA issued a Cleared decision on March 6, 2024, 99 days after receiving the submission on November 28, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K233794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2023 |
| Decision Date | March 06, 2024 |
| Days to Decision | 99 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 |