510(k) K240401
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) by
Origyn Medical Technology (Hangzhou) Co., Ltd.
— Product Code HIH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2024
- Date Received
- February 9, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type