510(k) K220890 ยท FMI Needle, Hypodermic, Single Lumen
IO Needle Safety Sheath
| Applicant | Actuated Medical, Inc., Bellefonte PA, US |
| Decision | Substantially Equivalent, Oct 31, 2022 |
| Received | Mar 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220890
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.