# K232623: Universal Endometrial Applicator Set (GM11009840)

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 9, 2024 after 224 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: 2 generations back to K871216 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980576: Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader, Varian Medical Systems, Inc. (1998) Summary page 4.

## Indications for use
The Universal Endometrial Applicator Set is indicated for use for treating cancer of the vagina, cervix, endometrium and uterus using HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K232623
Methodology: https://510kreport.com/methodology