Identity
- Trade Name
- HTx Image Processing System FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- This is the control unit for the scopes. It stores images and videos on its hard drive. It allows users to modify settings such as white balance and zoom. FDA UDI
- Model / Reference
- HTx1000 FDA UDI
- Description
- This is the control unit for the scopes. It stores images and videos on its hard drive. It allows users to modify settings such as white balance and zoom. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974880990017 FDA UDI
- 510(k) Number
- K211227 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rigid video hysteroscope
HTx Image Processing System by Suzhou AcuVu Medical Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- Hys. 029.15.3020a — Blazejewski MEDI-TECH GmbH · Class IIa
Cleared under the same submission
K211227 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suzhou AcuVu Medical Technology Co., Ltd.
Sources (2)
- FDA UDI 2d0b52c1-60d0-4e4b-b1a6-b468e2eadb62 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026