K250298
- 510(k) number
- K250298
- Device name
- 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 UT · US
- Product code
- HDB — Extractor, Vacuum, Fetal
- Decision date
- 2025-10-08
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250298.pdf
Official FDA record: K250298
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.