# K243939: Titanium Flexible Geometry FSD Applicator Set (GM11013400)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 3, 2025 after 73 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871217 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241853: Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve, Varian Medical Systems, Inc. (2024) Summary page 5.

## Indications for use
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

Source page: https://510kreport.com/device/K243939
Methodology: https://510kreport.com/methodology