# K072616: Axxent Vaginal Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, Inc.
- Decided: May 9, 2008 after 235 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- 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 K912555 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033371: Varian Intracavitary Brachytherapy Applicators, Varian Medical Systems (2003) Summary page 1.

## Indications for use
The Axxent Vaginal Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavitary brachytherapy in the vagina and rectum.

Source page: https://510kreport.com/device/K072616
Methodology: https://510kreport.com/methodology