K233043
- 510(k) number
- K233043
- Device name
- Smart Scope® CX
- Applicant
- Periwinkle Technologies Pvt., Ltd. IN
- Product code
- HEX — Colposcope (And Colpomicroscope)
- Decision date
- 2024-06-14
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K233043.pdf
Official FDA record: K233043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.