Titanium Flexible Geometry FSD Applicator Set (GM11013400)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243939 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 Titanium Flexible Geometry FSD Applicator Set (GM11013400) is a reusable, remote-controlled applicator system designed for high-dose-rate (HDR) brachytherapy. It is classified as a System, Applicator, Radionuclide, Remote-Controlled device and is intended for use in delivering precise radiation therapy to treat uterine, cervical, and vaginal cancers. The set includes intrauterine tandems with varying angles (15°, 30°, 45°), colpostat tandems, and optional interstitial ovoids, enabling flexible positioning for targeted treatment.
This device is supplied non-sterile and is intended for use in healthcare facilities by trained personnel. It is regulated under FDA 510(k) clearance (K243939) and MDR, classified as Class II with special controls. The applicators are reusable and designed for repeated use within a controlled clinical environment, adhering to regulatory standards for radiation therapy equipment. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety.
Frequently asked questions
What types of cancers is this applicator set designed to treat, and how does its flexible geometry help in targeting those areas?
The Titanium Flexible Geometry FSD Applicator Set is specifically designed for high-dose-rate (HDR) brachytherapy to treat uterine, cervical, and vaginal cancers. Its flexible geometry allows for precise positioning of intrauterine tandems (available in 15°, 30°, and 45° angles), colpostat tandems, and optional interstitial ovoids, enabling clinicians to adapt the applicator to the unique anatomy of each patient. This adaptability ensures targeted radiation delivery to the tumor while minimizing exposure to surrounding healthy tissue.
Is this applicator set reusable, and if so, what considerations should be taken into account for its maintenance and sterilization?
Yes, the Titanium Flexible Geometry FSD Applicator Set is designed for reuse within a controlled clinical environment. Since it is supplied non-sterile, it must undergo proper cleaning, inspection, and sterilization between uses to maintain functionality and safety. The manufacturer’s guidelines must be strictly followed to ensure compliance with regulatory standards for radiation therapy equipment, as improper handling could compromise performance or patient safety.
What angles are available for the intrauterine tandems included in this set, and how might they benefit treatment planning?
The set includes intrauterine tandems with three distinct angles: 15°, 30°, and 45°. These varying angles provide flexibility in treatment planning, allowing clinicians to position the applicator more precisely according to the patient’s anatomy. This adaptability helps optimize radiation delivery to the target area while accommodating differences in uterine shape or tumor location.
How is this device regulated, and what does the FDA 510(k) clearance (K243939) indicate about its safety and effectiveness?
The Titanium Flexible Geometry FSD Applicator Set holds FDA 510(k) clearance (K243939) under the Traditional 510(k) review process, with a decision code of SESE (Substantially Equivalent). This classification means the device meets the FDA’s requirements for safety and performance by demonstrating equivalence to a legally marketed predicate device. Additionally, it is classified under MDR (Medical Device Regulation) in the EU as Class II with special controls, ensuring it adheres to stringent regulatory standards for radiation therapy equipment.
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: Titanium Flexible Geometry FSD Applicator Set (GM11013400) (K243939 ..., Titanium Flexible Geometry FSD Applicat... (K243939) - FDA 510 (k), Titanium Flexible Geometry FSD Applicator Set… - FDA.report
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 | K243939 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K243939 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026