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Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator S…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172611

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K172611 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)

The Universal Cylinder Applicator Family is a remote-controlled radionuclide applicator system designed for intracavitary brachytherapy. These devices are used to deliver precise radiation doses to target tissues in the vagina, vaginal stump, cervix, uterus, endometrium, and rectum during high-dose-rate (HDR) or pulsed-dose-rate (PDR) treatments.

The applicators are supplied in segmented, odd, and even length configurations, including titanium probe sets, and are compatible with CT and MRI imaging. They are intended for single-use applications in radiology settings and are classified as Class II devices under FDA regulations (510(k) clearance) and the Medical Device Directive (MDD). Sterility and proper storage are critical for maintaining device integrity before use.

Frequently asked questions

What types of radiation treatments are these applicators designed for, and which anatomical sites can they target?

These applicators are specifically designed for high-dose-rate (HDR) and pulsed-dose-rate (PDR) intracavitary brachytherapy, delivering precise radiation doses to target tissues. They are used for treating the vagina, vaginal stump, cervix, uterus, endometrium, and rectum, ensuring localized radiation delivery for cancer therapy.

Are these applicators reusable or single-use, and what does that mean for sterilization and handling?

The Universal Cylinder Applicator Family is intended for single-use only. Since they are sterile upon packaging, they must remain unopened until use to maintain sterility. Proper storage conditions are critical to preserve device integrity before application, as reuse is not supported.

What length configurations and materials are available for the applicators, and how does that affect compatibility with imaging?

The applicators come in segmented, odd-length, and even-length configurations, including titanium probe sets. These designs ensure flexibility for different anatomical needs while remaining compatible with CT and MRI imaging, allowing for precise treatment planning and verification.

How is the regulatory approval status of these devices determined, and what does that mean for clinical use?

These devices hold FDA 510(k) clearance under the Medical Device Directive (MDD) and are classified as Class II under FDA regulations. The clearance was granted through a substantially equivalent determination by the Radiology (RA) Advisory Committee, confirming their safety and effectiveness for their intended use in radiology settings as remote-controlled radionuclide applicators.

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: Brachytherapy Applicator Catalog - Varian Oncology - PDF Catalogs ..., Universal Cylinder Applicator Family, Universal Segmented Cylinder ..., Universal Cylinder Applicator Family, Universal Segmented Cylinder ..., Universal Cylinder Applicator Family, Universal Segmented Cylinder ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Varian Medical Systems, Inc.

Sources (2)

  • FDA 510(k) K172611 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026