510(k) K243309 ยท FMI Needle, Hypodermic, Single Lumen
27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, May 29, 2025 |
| Received | Oct 21, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243309
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.