WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystosco…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212202 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 WiScope Digital Cystoscope System is a flexible/rigid cystoscope and accessories designed for endoscopic visualization of the urinary bladder and lower urinary tract. It integrates digital imaging technology to provide real-time, high-resolution video output for diagnostic and procedural guidance in urological examinations.
This system is supplied as a single-use digital flexible cystoscope with an accompanying image capture and processing unit. It is intended for use in sterile environments, such as operating rooms or clinical examination spaces, and is classified under FDA 510(k) and MDR regulatory frameworks. Multiple model and reference codes are associated with its components, ensuring compatibility with various procedural needs.
Frequently asked questions
Is the WiScope Digital Cystoscope System designed for reusable or single-use procedures, and how does this affect its use in clinical settings?
The WiScope Digital Cystoscope System is explicitly designed as a single-use device, as indicated by the term *‘WiScope Single-Use Digital Flexible Cystoscope’* in the description. This means each cystoscope is intended for one patient procedure only, eliminating the need for reprocessing and reducing infection risks in sterile environments like operating rooms or clinical examination spaces. Single-use design simplifies workflows by removing the need for cleaning, sterilization, or storage between uses.
What types of imaging technology does the WiScope System use, and how does it benefit diagnostic procedures?
The WiScope Digital Cystoscope System integrates digital imaging technology, providing real-time, high-resolution video output for endoscopic visualization of the urinary bladder and lower urinary tract. This allows clinicians to capture clear, detailed images during procedures, improving diagnostic accuracy and procedural guidance compared to traditional analog cystoscopes. The digital output also enables easier sharing and documentation of findings.
Are there multiple models or configurations available for the WiScope System, and how do I ensure compatibility with my existing workflows?
Yes, the WiScope Digital Cystoscope System includes multiple model and reference codes (listed under *openfda* and *registration_number*), ensuring compatibility with various procedural needs. These codes correspond to different components or configurations of the system, such as flexible or rigid cystoscopes and accessories. To ensure compatibility, verify the specific model or code you require aligns with your clinical workflows or consult OTU Medical’s technical support for guidance on selecting the appropriate configuration.
How should the WiScope Single-Use Digital Flexible Cystoscope be stored, and what precautions should be taken to maintain its integrity?
While the data does not specify exact storage instructions, the system is sterile and intended for single-use in sterile environments. To maintain integrity, store the device in its original, unopened packaging in a clean, dry location away from direct sunlight or extreme temperatures. Ensure the packaging remains intact until immediate use to preserve sterility and functionality. Always follow manufacturer guidelines for unpacking and handling to prevent contamination.
What regulatory pathways has the WiScope Digital Cystoscope System undergone, and how does this impact its adoption in clinical settings?
The WiScope Digital Cystoscope System has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, as noted in the authorizations section. This means the device has been evaluated for safety and performance against established standards, providing confidence in its clinical use. The regulatory route ensures compliance with U.S. and EU requirements, facilitating adoption in healthcare settings where these certifications are required. For specific adoption details, consult your facility’s procurement or regulatory compliance team.
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 | K212202 | Class II | Active |
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Manufacturer
- Manufacturer
- Otu Medical Inc.
- FDA Applicant
- OTU Medical, Inc.
Sources (2)
- FDA 510(k) K212202 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026