# K130251: Esophagus Bougie Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 13, 2013 after 40 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Varian Esophagus bougie set: named in the summary without a submission number

## Most influential descendants
- K161576: Esophagus Bougie Set (2016), 0 descendants of its own

## Indications for use
The Esophagus Bougie Set was designed to treat cancer of the esophagus. The Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used in conjunction with a high dose rate afterloader.

Source page: https://510kreport.com/device/K130251
Methodology: https://510kreport.com/methodology