HDB
- 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)
- 30
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250298 | 2025-10-08 | Clinical Innovations, LLC | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC |
Official FDA classification page: HDB
Classification and pathway per current FDA publications. Data from openFDA (CC0).