# K201279: ASSISTO Universal Applicator Clamping Device

- Pathway: 510(k) (Traditional)
- Applicant: Geomed Medizin-Technik GmbH & Co. KG
- Decided: Jul 10, 2020 after 58 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: 3 generations back to K003270 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170203: System, Applicator, Radionuclide, Remote Controlled, Kobold, LLC (2017) Summary page 4.

## Indications for use
The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment. Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K201279
Methodology: https://510kreport.com/methodology