# K170203: System, Applicator, Radionuclide, Remote Controlled

- Pathway: 510(k) (Traditional)
- Applicant: Kobold, LLC
- Decided: Jun 1, 2017 after 129 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 K003270 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091230: HDR Prostate Template and Accessories, Photon Technologies Corporation (2009) Summary page 4.

## Most influential descendants
- K201279: ASSISTO Universal Applicator Clamping Device (2020), 0 descendants of its own

## Indications for use
The Kobold Prostate HDR Template and Stepper Template are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate. The Stainless Steel Interstitial Needles and corresponding stylets are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.

Source page: https://510kreport.com/device/K170203
Methodology: https://510kreport.com/methodology