HEX
- Product code
- HEX
- Device name
- Colposcope (And Colpomicroscope)
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.1630
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 56
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233043 | 2024-06-14 | Periwinkle Technologies Pvt., Ltd. | Smart Scope® CX | FDA |
Official FDA classification page: HEX
Classification and pathway per current FDA publications. Data from openFDA (CC0).