HGE
- Product code
- HGE
- Device name
- Amniotome
- Device class
- Class 1
- 21 CFR
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 6
Official FDA classification page: HGE
Classification and pathway per current FDA publications. Data from openFDA (CC0).