# K123815: Surface Applicator Set with Leipzig-Style Cone

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 11, 2013 after 89 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912555 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.

## Most influential descendants
- K162018: Surface Applicator Set (2017), 0 descendants of its own

## Recalls of this device
- May 18, 2015 · Class II · Z-1829-2015: Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. T

## Indications for use
The Surface Applicator Set with Leipzig-style cone-GM11O10080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.

Source page: https://510kreport.com/device/K123815
Methodology: https://510kreport.com/methodology