Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator S…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160516 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a System, Applicator, Radionuclide, Remote-Controlled, designed for use in brachytherapy procedures. It comprises applicators for precise placement of radioactive sources in cylindrical, segmented cylindrical, stump, and cervical configurations, enabling targeted radiation delivery in radiology settings.
The applicators are supplied as single-use, non-sterile components intended for sterile preparation prior to use. They are classified as Class II devices under FDA regulations (892.5700) and have been cleared via a 510(k) submission, with authorization under the Medical Device Directive (MDD). Various lengths and configurations are available to accommodate different anatomical applications, ensuring compatibility with remote-controlled radionuclide delivery systems.
Frequently asked questions
Are these applicators intended for reuse or are they single-use only? Why does this matter in brachytherapy?
These applicators are explicitly designed as single-use, non-sterile components that require sterile preparation prior to use. In brachytherapy, sterility is critical to prevent infection and ensure patient safety, as the applicators come into direct contact with internal tissues. Single-use design also eliminates cross-contamination risks between patients, which is particularly important in radiation oncology where precision and contamination control are paramount.
What anatomical applications are these applicators designed for, and how do the different lengths and configurations help?
The Universal Cylinder Applicator Family and related sets are engineered for targeted radiation delivery in cylindrical, segmented cylindrical, stump, and cervical configurations, accommodating various anatomical sites. The odd/even lengths and segmented designs allow clinicians to match the applicator to the specific treatment area, ensuring proper source placement and dose distribution. This flexibility is essential for procedures like prostate, cervical, or vaginal brachytherapy, where precise conformance to tissue shapes is required.
How does the remote-controlled aspect of this system impact its use in clinical settings?
The remote-controlled design enables operators to manipulate the applicators and radioactive sources from a safe distance, minimizing radiation exposure to staff while maintaining precision. This is particularly valuable in brachytherapy, where sources are highly radioactive and require careful handling. The remote control allows for real-time adjustments during procedures, improving accuracy and patient safety.
What regulatory pathways have been followed for these devices, and what does that mean for clinicians?
These applicators were cleared via an FDA 510(k) submission under the Medical Device Directive (MDD), confirming they meet U.S. and EU regulatory standards for Class II devices (FDA classification 892.5700). Clinicians can rely on this clearance as evidence of safety and performance, though they should always follow institutional protocols and manufacturer guidelines for sterile preparation and use, as the devices are non-sterile as shipped.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160516 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K160516 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026