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Urologix, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 13355 10th Ave N., Plymouth, MN, 55441
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EUDAMED SRN: —
FDA FEI Number: 3000718675
DUNS Number: —

Catalogue (9)

Device	Model / Reference	Registries	Class	Status
Targis	PT1038	FDA UDI	Class III	Active
Targis	PT1036	FDA UDI	Class III	Active
Targis	PT1034	FDA UDI	Class III	Active
Targis	RB3131A	FDA UDI	Class III	Active
Prostiva Hand Piece	8929	FDA UDI	Class II	Active
Targis	RB3131A	FDA UDI	Class III	Active
Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope	K142248	FDA 510(k)	Class II	Active
Targis Targeted Transurethral Thermoablation System (targis System): New Pouch Sealer	P970008	FDA PMA	Class III	Active
Urologix Prostatron System	P950014	FDA PMA	Class III	Active

Related Companies

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 21, 2013	Z-0182-2014	—	terminated	A Hand Piece high deployment force exceeded the maximum specification.
Apr 28, 2011	Z-2710-2011	—	terminated	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 Coolant Bag and a RTU Plus balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sensor Module. This leak is detectabl
Feb 18, 2010	Z-1174-2010	—	terminated	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 involves a discrepancy in the"Use Before" date printed on the product label. In the affected lots, the "Use Before" date , commonly known as the expiration date, is printed as 2012-12 when it should r
Mar 16, 2007	Z-0721-2007	—	terminated	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	Z-0720-2007	—	terminated	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.
Dec 10, 2003	Z-0345-04	—	terminated	During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal temperature reading.