Cystoscope 4.0mm autoclavable 0° WL 302mm +3 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171336 FDA 510(k)
- FDA Product Code
- FAJ FDA 510(k)
- Models / Variants
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)
This device comprises a cystoscope, hysteroscope, cysto-urethroscope sheath, and an adapter bridge. The cystoscope and hysteroscope are rigid, 4.0mm diameter endoscopes with a 0° viewing angle and a working length of 302mm, designed for internal visualisation of the bladder and uterine cavity, respectively. The 19 French sheath facilitates urethral access, while the bridge adapter enables compatibility with sheath sizes ranging from 17 to 25 French.
The device is autoclavable, intended for reusable clinical use in urological and gynaecological procedures. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) and MDR regulatory frameworks. Compatible with MRI environments, it is classified under Class II medical devices (OpenFDA: FAJ, 876.1500) and authorised for use in gastroenterology and urology settings. Storage and handling follow manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of procedures is this device kit primarily designed for, and how does the 4.0mm diameter help in those applications?
This device kit is designed for urological and gynaecological procedures, specifically for internal visualisation of the bladder (via the cystoscope) and the uterine cavity (via the hysteroscope). The 4.0mm diameter allows for precise and minimally invasive access to these areas, reducing patient discomfort and potential trauma while still providing clear visualisation for diagnostic and therapeutic interventions.
Is this device kit reusable, and if so, what cleaning and sterilisation methods are recommended?
Yes, this device kit is autoclavable and intended for reusable clinical use. The manufacturer recommends following standard autoclave sterilisation protocols to ensure proper cleaning and sterilisation between uses. Adherence to manufacturer guidelines for storage and handling is also essential to maintain sterility and functionality.
What sheath sizes does the bridge adapter accommodate, and why is this flexibility important?
The bridge adapter in this kit enables compatibility with cysto-urethroscope sheath sizes ranging from 17 to 25 French. This flexibility is important because it allows clinicians to select the appropriate sheath size for different patient anatomies, ensuring a better fit and reducing the risk of complications during insertion.
Can this device be used in MRI environments, and how might that affect its selection for certain clinical settings?
Yes, this device is explicitly noted as compatible with MRI environments. This feature makes it suitable for use in clinical settings where MRI scans are frequently required post-procedure, as it eliminates the need for additional non-MRI-compatible equipment and streamlines workflow.
How is the device kit supplied, and what should clinicians consider when ordering to ensure proper use?
The device kit is supplied either sterile or non-sterile, as specified by the manufacturer. Clinicians should verify the sterility status when ordering to ensure it aligns with their procedural needs. Additionally, they should confirm the inclusion of all components (cystoscope, hysteroscope, sheath, and bridge adapter) and follow the manufacturer’s storage instructions to preserve functionality and sterility until use.
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 | K171336 | Class II | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (2)
- FDA 510(k) K171336 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026