Clearance Summary
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) received FDA 510(k) clearance under submission number K250298, sponsored by Clinical Innovations, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-10-08.
- Submission: K250298
- Applicant / Sponsor: Clinical Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 2025-10-08
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.