Single-Use Video Ureterorenoscope SVU-220US
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241639 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 Single-Use Video Ureterorenoscope SVU-220US is a flexible, single-use endoscope designed for visualisation of the urinary tract, including the ureter and renal pelvis. It incorporates an integrated video system to provide real-time imaging for diagnostic and therapeutic procedures in urology and gastroenterology.
This device is intended for single-use in clinical settings and is supplied sterile. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorisation. The SVU-220US is not MRI-compatible and must be handled according to standard sterile instrument protocols. No additional sizes or special storage requirements are specified beyond standard single-use medical device handling.
Frequently asked questions
What clinical specialties is this device primarily intended for, and how does that translate to typical use cases?
The Single-use Video Ureterorenoscope (SVU-220US) is designed for use in gastroenterology and urology, as indicated by its advisory committee classification. Clinically, this means it is primarily used for visualizing the urinary tract—including the ureter and renal pelvis—during diagnostic and therapeutic procedures. For example, urologists may use it to inspect kidney stones, strictures, or tumors, while gastroenterologists might employ it for similar evaluations in the upper urinary tract.
Is this device reusable, or is it strictly for single-use? What does that mean for infection control and cost management?
The SVU-220US is strictly single-use, as explicitly stated in its description. This design eliminates the need for reprocessing, reducing infection risks associated with multi-use devices. For cost management, hospitals must account for the higher per-procedure expense of single-use scopes but avoid the labor, time, and potential contamination risks tied to reprocessing reusable instruments.
How should this device be stored, and are there any special handling requirements beyond standard sterile medical device protocols?
The device is supplied sterile, but no additional storage requirements are specified beyond standard protocols for single-use medical devices. This means it should be stored in a clean, dry environment, protected from physical damage, and used within its expiration date. Since it’s not MRI-compatible, it should also be stored away from magnetic fields if applicable to your facility’s layout.
What regulatory pathways has this device undergone, and what does that imply for its adoption in clinical settings?
The SVU-220US has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and effectiveness in the U.S. and EU markets, respectively. This implies it can be legally marketed and used in those regions after compliance with local healthcare protocols. The clearance type is classified as *Special*, which may indicate a more rigorous review process for innovative or complex devices.
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 | K241639 | Class II | Active |
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Manufacturer
- Manufacturer
- HUGER Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K241639 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026