# K060349: Proguide Needle Set

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: Mar 10, 2006 after 28 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K082530: Applicators for Afterloading Brachytherapy (2008), 0 descendants of its own
- K082264: Contura Lumen Marker (2008), 0 descendants of its own

## Indications for use
The Proguide Needle Set is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

Source page: https://510kreport.com/device/K060349
Methodology: https://510kreport.com/methodology