510(k) K243581 ยท FMI Needle, Hypodermic, Single Lumen
K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Apr 4, 2025 |
| Received | Nov 14, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243581
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.