# K022635: Kuske Breast Applicator Set, Model 189.006

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: Sep 6, 2002 after 29 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: 2 generations back to K864210 (1986). 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)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 2.

## Indications for use
Nucletron Kuske Breast Applicator Set is intended for use with Interstitial breast brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

Source page: https://510kreport.com/device/K022635
Methodology: https://510kreport.com/methodology