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ClearVision Single Use Hysteroscope & Image Processing System - EHS-Op6001
FDA 510(k)Class II (US FDA 510(k))
510(k) K240401
Identifiers
- 510(k) Number
- K240401 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
- Models / Variants
- EHS-Dx4001 FDA 510(k)EHS-Op5001 FDA 510(k)EHS-Op6001 FDA 510(k)EHS-IPS01US FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ClearVision Single Use Hysteroscope & Image Processing System - EHS-Op6001 by OriGyn Medical Technology (Hangzhou) Co., Ltd. — Class II — FDA_510K — listed in…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240401 | Class II | Active |
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Manufacturer
- Manufacturer
- OriGyn Medical Technology (Hangzhou) Co., Ltd.
Sources (1)
- FDA 510(k) K240401 24 fields · synced Jun 18, 2026