HIB
- Product code
- HIB
- Device name
- Speculum, Vaginal, Nonmetal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 72
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252208 | 2026-03-06 | Ford Medtech, LLC | JFord Speculum Sleeve |
Official FDA classification page: HIB
Classification and pathway per current FDA publications. Data from openFDA (CC0).