510(k) K253403 · LKF Cannula, Manipulator/Injector, Uterine
FemVue® Controlled Saline-Air Device (FSA-300)
| Applicant | Femasys, Inc., Cumming GA, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253403
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.