# K152018: Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Sep 11, 2015 after 52 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: 4 generations back to K871217 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141624: Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with Mandrin, 2.0 MM Diameter, Length 113, Varian Medical Systems, Inc. (2015) Summary page 4.

## Indications for use
The Cleaning Cap is intended to close the lumens of applicator parts during the cleaning and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired. The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips. The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.

Source page: https://510kreport.com/device/K152018
Methodology: https://510kreport.com/methodology