ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
FDA 510(k) clearance K240401 · decided 2024-07-26
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-09
- Decision date
- 2024-07-26
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.