Identity
- Trade Name
- HTx Disposable Hysteroscope FDA UDI
- Generic Name
- Rigid video hysteroscope FDA UDI
- Device Name
- Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine lesions and take a biopsy. The outer diameter of the scope is less than or equal to 4.5 mm. FDA UDI
- Model / Reference
- HTx40 FDA UDI
- Description
- Disposable hysteroscope with a working channel suitable for 5Fr tools to cut and remove uterine lesions and take a biopsy. The outer diameter of the scope is less than or equal to 4.5 mm. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974880990031 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
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rigid video hysteroscope
HTx Disposable Hysteroscope by Suzhou AcuVu Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 9af93c53-0df9-44d9-85ff-fe3dc0aa4c27 36 fields · synced May 30, 2026