510(k) K212095 ยท FMI Needle, Hypodermic, Single Lumen
SurGuard3 Safety Hypodermic Needle
| Applicant | Terumo Europe N.V., Leuven, BE |
| Decision | Substantially Equivalent, Aug 22, 2022 |
| Received | Jul 6, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212095
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.