# K080871: Trocar Point Titanium Needle Sets, Round Point Titanium Needle Sets

- Pathway: 510(k) (Special)
- Applicant: Nucletron Corporation
- Decided: Apr 29, 2008 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
Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.

Source page: https://510kreport.com/device/K080871
Methodology: https://510kreport.com/methodology