# K980576: Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 2, 1998 after 258 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 K871216 (1987). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871216: Hilaris-Nori Endometrial Applicator, Mick Radio-Nuclear Instruments, Inc. (1987) Summary page 1.

## Most influential descendants
- K232623: Universal Endometrial Applicator Set (GM11009840) (2024), 0 descendants of its own
- K160021: Varian Sterilization Boxes (2016), 0 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 Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.

Source page: https://510kreport.com/device/K980576
Methodology: https://510kreport.com/methodology