VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223926 FDA 510(k)
- FDA Product Code
- FAJ 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 VersaVue Single-Use Flexible Cystoscope is classified as a Cystoscope and Accessories, Flexible/Rigid (OpenFDA: FAJ, Regulation Number 876.1500). It is a single-use, sterile, flexible endoscope designed for endoscopic visualization and surgical procedures within the lower urinary tract, including the bladder and urethra. The device integrates with a compatible display system (VersaVue Tablet or VersaVue Video Box) for real-time imaging.
This system is intended for use in clinical and surgical settings, including outpatient clinics and operating rooms. The cystoscope is supplied sterile as packaged and is non-reusable, eliminating the need for reprocessing. It is compatible with MRI environments and includes multiple model variants (FEI numbers listed in specifications). Authorized under FDA 510K and MDR, the device adheres to regulatory standards for flexible cystoscopes and associated accessories.
Frequently asked questions
What clinical settings is the VersaVue Single-Use Flexible Cystoscope designed for, and why is this important for my practice?
The VersaVue Single-Use Flexible Cystoscope is specifically designed for use in both clinical and surgical environments, including outpatient clinics and operating rooms. This versatility makes it suitable for a wide range of procedures involving the lower urinary tract, such as bladder and urethra examinations. Its single-use, sterile design eliminates the need for reprocessing, reducing the risk of cross-contamination and ensuring consistent hygiene, which is particularly important in sterile surgical settings.
How do I know which model of the VersaVue Single-Use Flexible Cystoscope is compatible with my existing equipment?
The VersaVue system includes multiple model variants, each identified by a unique FEI number (e.g., 3003687489, 3015139943, etc.). While the device is designed to integrate with the VersaVue Tablet or VersaVue Video Box for real-time imaging, compatibility is primarily determined by the specific clinical requirements and the intended procedure. Contacting Medimaging Integrated Solution, Inc. (Miis) with your existing equipment details or FEI numbers can help confirm the correct model for your setup.
Is the VersaVue Single-Use Flexible Cystoscope safe to use in an MRI environment, and what does that mean for my facility?
Yes, the VersaVue Single-Use Flexible Cystoscope is explicitly designed to be compatible with MRI environments. This means it can be safely used in facilities where MRI scans are performed, reducing the need for additional equipment or procedures to ensure safety during imaging. This feature is particularly useful in multi-disciplinary settings where both cystoscopy and MRI may be required.
How should I store the VersaVue Single-Use Flexible Cystoscope, and what are the implications for shelf life or expiration?
The device is supplied sterile as packaged, which implies it should be stored according to the manufacturer’s instructions to maintain sterility and functionality. While the exact storage conditions (e.g., temperature, humidity) are not detailed here, single-use devices like this typically require protection from physical damage and contamination. Always refer to the packaging or accompanying documentation for specific storage guidelines. Since it is single-use, expiration dates are critical—ensure you use it before the indicated date to guarantee performance and safety.
Why is the VersaVue system considered single-use, and what are the advantages of this design for my practice?
The VersaVue Single-Use Flexible Cystoscope is designed as a single-use device to eliminate the need for reprocessing, which reduces the risk of infection, cross-contamination, and device-related complications. This design simplifies workflows by removing the steps required for cleaning, sterilization, and inspection between uses. Additionally, it ensures consistent performance and hygiene, which is particularly valuable in clinical settings where sterility is paramount, such as operating rooms or high-volume outpatient clinics.
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: VersaVue Single-Use Flexible Cystoscope and Tablet, VersaVue™ Single-Use Flexible Cystoscope and Tablet, VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue ...
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 | K223926 | Class II | Active |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution, Inc (Miis)
Sources (2)
- FDA 510(k) K223926 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026