# K980601: Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Assoc., Inc.
- Decided: Oct 21, 1998 after 246 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 K890485 (1989). 1 ancestor in all.
18 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890485: Wang Front Loading Applicator, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.

## Most influential descendants
- K061241: Biolucent Applicator, Model Rta-XX (2006), 17 descendants of its own
- 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

## Indications for use
The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.

Source page: https://510kreport.com/device/K980601
Methodology: https://510kreport.com/methodology