510(k) K253047 · FMI Needle, Hypodermic, Single Lumen
PRESSONE
| Applicant | Nipro Medical Corporation, Miami FL, US |
| Decision | Substantially Equivalent, Mar 24, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253047
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.