# K063815: Varian Esophagus Bougie Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Mar 1, 2007 after 69 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: 2 generations back to K912555 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891131: Gammamed 12I, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.

## Most influential descendants
- K082530: Applicators for Afterloading Brachytherapy (2008), 0 descendants of its own

## Indications for use
The Varian Esophagus Bougie is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a Varian high dose rate afterloader.

Source page: https://510kreport.com/device/K063815
Methodology: https://510kreport.com/methodology