NXTHERA

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0262-2018Class IIRezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane SuiJuly 28, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K180237Rezum SystemFebruary 27, 2018
K160417Rezum SystemMarch 17, 2016
K150786Rezum SystemAugust 27, 2015