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HDB

Extractor, Vacuum, Fetal

Product code
HDB
Device name
Extractor, Vacuum, Fetal
Device class
Class 2
21 CFR
21 CFR 884.4340
Medical specialty
Obstetrics/Gynecology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
30 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-08.

NumberDecision dateApplicantDevice nameSummary
K2502982025-10-08Clinical Innovations, LLCKiwi® Complete Vacuum Delivery System, OmniCup® (VAC…PDF

1 summaries are archived here for direct download.

Official FDA classification page: HDB
Classification and pathway per current FDA publications. Data from openFDA (CC0).