510(k) K254273 ยท FMI Needle, Hypodermic, Single Lumen
Verisafe Safety Sterile Needles (SSN)
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Dec 30, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254273
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.