# K240495: Flexible Fixation Device for Gynecological Applicators (GM11001960)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 9, 2024 after 79 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 K912555 (1991). 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)
- K151657: Shielded Applicator Set, Cervical Stop, Varian Medical Systems, Inc. (2015) Summary page 4.

## Indications for use
The Flexible Fixation Device for gynecological applicators is intended for cancer treatment of the vagina, vaginal stump, cervix, uterus, endometrium or rectum using HDR or PDR Brachytherapy.

Source page: https://510kreport.com/device/K240495
Methodology: https://510kreport.com/methodology