Urologix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0182-2014Class IIProstiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The ProstOctober 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K142248Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode,February 20, 2015