510(k) K251447 ยท FMI Needle, Hypodermic, Single Lumen
K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Jul 8, 2025 |
| Received | May 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251447
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.