510(k) K262090 ยท MQK Labware, Assisted Reproduction
Fertilis microICSI Device
| Applicant | Fertilis Pty, Ltd., Adelaide, AU |
| Decision | Substantially Equivalent, Oct 9, 2026 |
| Received | Jun 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262090
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.