510(k) K250700 ยท FMI Needle, Hypodermic, Single Lumen
Pen Injector Needle 32.5
| Applicant | Terumo Corporation, Shibuya-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Nov 21, 2025 |
| Received | Mar 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250700
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.