K231792 is an FDA 510(k) clearance for the VeriSafe Safety sterile syringes. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on September 28, 2023, 100 days after receiving the submission on June 20, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K231792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2023 |
| Decision Date | September 28, 2023 |
| Days to Decision | 100 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 |