# K033371: Varian Intracavitary Brachytherapy Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Dec 24, 2003 after 64 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912555 (1991). 2 ancestors in all.
29 later devices descend from it; 8 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.

## Most influential descendants
- K070659: Biolucent Applicator Kit (2007), 13 descendants of its own
- K080565: Modification to: Savi Applicator Kit (2008), 12 descendants of its own
- K081677: Savi Applicator Kit (2008), 11 descendants of its own
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own

## Recalls of this device
- Jul 13, 2011 · Not classified · Z-3055-2011: Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error.
- May 20, 2010 · Not classified · Z-0282-2012: The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.

## Indications for use
The applicators will be used with the VanSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.

Source page: https://510kreport.com/device/K033371
Methodology: https://510kreport.com/methodology