# K241853: Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 7, 2024 after 133 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: 3 generations back to K871217 (1987). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K120731: Titanium Fletcher-Style Applicator Set-Defined Geometry, Varian Medical Systems, Inc. (2012) Summary page 5.

## Most influential descendants
- 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 – Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy. The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K241853
Methodology: https://510kreport.com/methodology