K213560 is an FDA 510(k) clearance for the Verifine Safety Syringe with Fixed Needle. 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 April 5, 2022, 147 days after receiving the submission on November 9, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K213560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2021 |
| Decision Date | April 05, 2022 |
| Days to Decision | 147 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 |