# K120731: Titanium Fletcher-Style Applicator Set-Defined Geometry

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 6, 2012 after 89 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: 2 generations back to K871217 (1987). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980590: Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate Afterloader, Varian Medical Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K241853: Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (2024), 2 descendants of its own
- K250299: CT/ MR Tandem and Ovoid Set (2025), 0 descendants of its own
- K243939: Titanium Flexible Geometry FSD Applicator Set (GM11013400) (2025), 0 descendants of its own

## Indications for use
The Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.

Source page: https://510kreport.com/device/K120731
Methodology: https://510kreport.com/methodology