# P970008: Targis (T3) System

- Pathway: PMA
- Applicant: Urologix, LLC
- Decided: Aug 22, 1997 after 179 days
- Product code: MEQ (System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 28, 2011 · Not classified · Z-2710-2011: Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a C
- Feb 18, 2010 · Not classified · Z-1174-2010: Urolgix is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis System. The reason for this Recall is a labeling error only; the issue invo
- Mar 16, 2007 · Not classified · Z-0720-2007: The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
- Mar 16, 2007 · Not classified · Z-0721-2007: The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.

Source page: https://510kreport.com/device/P970008
Methodology: https://510kreport.com/methodology