510(k) K253622 ยท FMI Needle, Hypodermic, Single Lumen
Safety Pen Needle
| Applicant | Ningbo Medsun Medical Co., Ltd., Ningbo, CN |
| Decision | Substantially Equivalent, Mar 18, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253622
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.