Device Listing 2057720920

Listing Summary#

Listing key
2057720920
Premarket submission
K250298
Device
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
Product code
HDB
Decision date
2025-10-08