510(k) K250298 · HDB Extractor, Vacuum, Fetal
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
| Applicant | Clinical Innovations, LLC, Murray UT, US |
| Decision | Substantially Equivalent, Oct 8, 2025 |
| Received | Jan 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250298
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.