# K161576: Esophagus Bougie Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 2, 2016 after 117 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: 1 generation back to K130251 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130251: Esophagus Bougie Set, Varian Medical Systems, Inc. (2013) Summary page 4.

## 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 with a high dose rate afterloader.

Source page: https://510kreport.com/device/K161576
Methodology: https://510kreport.com/methodology