# K193240: Universal Cylinder Applicator Family

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Aug 17, 2020 after 266 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: 6 generations back to K912555 (1991). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172611: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths, Varian Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K252717: MAASTRO Rectal Applicator Set (2026), 0 descendants of its own

## Indications for use
The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy. The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Multi-Channel Cylinder Set is indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus, endometrium and rectum using HDR or PDR brachytherapy. The Universal Cervix Probe Sets in combination with the Universal Multi-Channel Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Titanium Cervix Probe Sets in combination with the Universal Multi-Channel Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Interstitial Cylinder Set is indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus and endometrium using intracavitary and interstitial HDR or PDR brachytherapy. The Universal Cervix Probe Sets in combination with the Universal Interstitial Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Titanium Cervix Probe Sets in combination with the Universal Interstitial Cylinder Set are indicated for use for cancer treatment of the vagina, cervix, uterus and endometrium using HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K193240
Methodology: https://510kreport.com/methodology