HTx Disposable Hysteroscope
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Histeroscopio Desechable HTx EUDAMEDHTx Disposable Hysteroscope FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- HTx Disposable Hysteroscope EUDAMEDDisposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of the scope is less than or equal to 6.2 mm. FDA UDI
- Model / Reference
- HTx60s EUDAMEDFDA UDIHTx40, HTx60, HTx60s, HTx60t, HTx40-L, HTx60c, HTx60-L EUDAMED
- Description
- Disposable hysteroscope with a working channel suitable for 9Fr tools to cut and remove uterine lesions. The outer diameter of the scope is less than or equal to 6.2 mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 26974880991902 EUDAMED06974880990048 FDA UDI
- Basic UDI-DI
- 697488099ADH001ML EUDAMED
- 510(k) Number
- K211227 FDA UDI
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
- GMDN Term
- Rigid video hysteroscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Rigid video hysteroscope
HTx Disposable Hysteroscope 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
MDR
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 c7f1f52b-28d3-42c3-a81d-325c56c846ac 36 fields · synced Jun 14, 2026
- EUDAMED 5cc179f9-e551-4a06-b317-472aaa3b786b 61 fields · synced Jun 11, 2026