# K083734: Axxent Surface Applicator, Model 710257

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, Inc.
- Decided: Feb 11, 2009 after 57 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 K864210 (1986). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073107: Valencia Skin Applicator Set, Model: 189.701, Nucletron Corporation (2007) Summary page 1.

## Most influential descendants
- K130549: Intrabeam Flat Applicator, Intrabeam Surface Applicator (2013), 2 descendants of its own
- K162568: Intrabeam 600 (2016), 1 descendant of its own
- K241174: INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (2025), 0 descendants of its own

## Indications for use
The Axxent Surface Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver surface brachytherapy, including lntraoperative Radiation Therapy (IORT) during the time the treatment site is exposed surgically.

Source page: https://510kreport.com/device/K083734
Methodology: https://510kreport.com/methodology