Endoscopic Video Image Processor, Single-Use Video Hysteroscope
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232003 FDA 510(k)
- FDA Product Code
- HIH 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)
This device is a Single-Use Video Hysteroscope, classified as a Class II medical device under FDA regulations. It combines endoscopic imaging with video processing to enable visualization of the uterine cavity, facilitating diagnostic and therapeutic procedures in obstetrics and gynecology. The integrated video processor captures high-quality images and video for real-time assessment, supporting minimally invasive interventions such as biopsies or polyp removal.
The device is designed for single-use in clinical settings, ensuring sterility and reducing infection risks. It is intended for use in MRI-safe environments and is supplied as a complete, ready-to-use system. Authorized under FDA 510(k) clearance (K232003) and MDR, it adheres to regulatory standards for obstetrics/gynecology applications. No reusable components are specified, and storage conditions must comply with manufacturer guidelines for single-use medical devices.
Frequently asked questions
What clinical procedures is this single-use video hysteroscope primarily designed to support in obstetrics and gynecology?
This device is designed to enable real-time visualization of the uterine cavity, making it suitable for diagnostic and therapeutic procedures such as biopsies, polyp removal, and other minimally invasive interventions in obstetrics and gynecology. The integrated video processor captures high-quality images and video, aiding in accurate assessment during these procedures.
Is this device intended for reuse, or is it strictly single-use? How does that affect its sterility?
The device is explicitly designed for single-use only, ensuring sterility and eliminating the risk of cross-contamination between patients. Since it’s not reusable, there are no reusable components to clean or sterilize, reducing infection risks and simplifying clinical workflows.
What storage conditions should be followed for this single-use video hysteroscope?
While the exact storage guidelines are manufacturer-specific, single-use medical devices like this typically require protection from extreme temperatures, moisture, and physical damage. The device should be stored in its original packaging until use, adhering to the manufacturer’s instructions to maintain integrity and sterility.
Does this device have any special compatibility requirements, such as MRI safety?
Yes, this device is explicitly designed for use in MRI-safe environments, meaning it can be safely used alongside MRI machines without interfering with imaging or posing risks to patients. This is particularly important for procedures involving both hysteroscopy and MRI compatibility.
How is this device supplied, and does it come as a complete system ready for immediate use?
The device is supplied as a complete, ready-to-use system, meaning no additional components or setup are required beyond unpacking and connecting it to compatible imaging equipment. This streamlines workflows in clinical settings by minimizing preparation time.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Guangzhou Red Pine Medical Instrument Co.,Ltd., Endoscopic Video Image Processor, Single-Use Video Hysteroscope ..., K232003 - Endoscopic Video Image Processor, Single-Use V..., Endoscopic Video Image Processor, Single-Use Video Hysteroscope
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232003 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Red Pine Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K232003 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026