Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Mode…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220159 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flexible Ureterorenoscope (Models: US31D-12-EU, US31D-12-US) is a medical device classified as a ureteroscope and accessories, flexible/rigid. It is designed for diagnostic and therapeutic procedures within the urinary tract, enabling visualization and intervention in the ureter and renal pelvis. This device facilitates minimally invasive access to treat conditions such as kidney stones, strictures, or obstructions through its flexible shaft and integrated optics.
Used primarily in urology and gastroenterology settings, this device is supplied as a reusable instrument and requires appropriate sterilization between uses. It is not MRI-safe and must be handled with caution in magnetic environments. The device is authorized under FDA 510(k) clearance and MDR compliance, ensuring regulatory adherence for clinical use. Models US31D-12-EU and US31D-12-US are differentiated by regional specifications, with both adhering to the same technical and safety standards.
Frequently asked questions
What clinical specialties primarily use this ureterorenoscope, and why is it designed for those fields?
This flexible ureterorenoscope is primarily used in urology and gastroenterology settings. Its flexible shaft and integrated optics allow for minimally invasive visualization and intervention within the urinary tract, particularly for diagnosing and treating conditions like kidney stones, strictures, or obstructions in the ureter and renal pelvis—common concerns in these specialties.
Is this device single-use or reusable, and what sterilization process should be followed between uses?
The Flexible Ureterorenoscope (Models US31D-12-EU/US31D-12-US) is reusable and requires appropriate sterilization between uses to ensure safety and efficacy. The manufacturer recommends following standard medical device sterilization protocols, such as autoclaving or chemical sterilization, as outlined in their instructions for use.
Are there any regional differences between the US31D-12-EU and US31D-12-US models, and how do they affect clinical use?
The US31D-12-EU and US31D-12-US models are differentiated by regional specifications, meaning they comply with local regulatory requirements (e.g., MDR for EU and FDA 510(k) for the US). Clinically, they share identical technical and safety standards, so no functional differences exist—only compliance with regional regulations.
Can this device be used in an MRI environment, and why is this important for clinicians to know?
No, this ureterorenoscope is not MRI-safe. Clinicians must handle it with caution in magnetic environments, as exposure to MRI fields could compromise the device’s integrity or pose safety risks to patients. Always confirm the room’s magnetic field strength before use.
What regulatory pathways does this device follow, and how does that impact its availability?
The device is authorized under FDA 510(k) clearance and MDR compliance, ensuring it meets U.S. and European regulatory standards for safety and performance. This means it is legally marketable in those regions after passing the respective submission processes, though availability depends on local distribution agreements with authorized distributors.
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.
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 | K220159 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- FDA Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K220159 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026