# K161688: Advanced Gynecological Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Jan 27, 2017 after 221 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.
No later device cites it as a predicate yet.
0 of 6 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 4.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 4.

## Recalls of this device
- Apr 3, 2026 · Class II · Z-2711-2026: 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 intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Source page: https://510kreport.com/device/K161688
Methodology: https://510kreport.com/methodology