# K201272: Geneva

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Jul 16, 2020 after 65 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091154: Utrecht Interstitial Fletcher CT/MR Applicator Set, Model 110.270, Interstitial Ring CT/MR Applicator Set,Model 110.330,, Nucletron Corporation (2009) Summary page 6.

## Most influential descendants
- K250289: Intracavitary/Interstitial System (2025), 0 descendants of its own

## Recalls of this device
- Apr 3, 2026 · Class II · Z-2712-2026: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

## Indications for use
The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.

Source page: https://510kreport.com/device/K201272
Methodology: https://510kreport.com/methodology