# K242961: Intraluminal Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Nov 26, 2024 after 62 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: 3 generations back to K912555 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151022: Intraluminal Applicator Set, Varian Medical Systems, Inc. (2015) Summary page 6.

## Indications for use
The lntraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

Source page: https://510kreport.com/device/K242961
Methodology: https://510kreport.com/methodology