K240401
- 510(k) number
- K240401
- Device name
- ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
- Applicant
- Origyn Medical Technology (Hangzhou) Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2024-07-26
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240401.pdf
Official FDA record: K240401
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.