# K132889: Fletcher CT/MR Shielded Applicator Set (6 MM) Fletcher CT/MR Shielded Applicator Set (4 MM)

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Feb 26, 2014 after 163 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: 3 generations back to K864210 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983341: Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set, Fletcher Williamson Applicator SE, Nucletron Corp. (1999) Summary page 1.

## Recalls of this device
- Apr 3, 2026 · Class II · Z-2710-2026: 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 Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Source page: https://510kreport.com/device/K132889
Methodology: https://510kreport.com/methodology