Tenex Health Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
7
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1552-2014Class IITX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-10April 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K181367Tenex Health TX System with the TXP MicroTipAugust 28, 2018
K153299Tenex Health TX SystemMarch 3, 2016
K123640TX1 TISSUE REMOVAL SYSTEMMarch 20, 2013