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Monteris Medical Corp

FDA Regulatory Profile

Summary

Total Recalls
4 (2 Class I)
510(k) Clearances
20
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0194-2018Class IMONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.October 5, 2017
Z-1614-2016Class INeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFMarch 25, 2016
Z-0228-2015Class IIFullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. ThOctober 3, 2014
Z-0227-2015Class IISideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. ThesOctober 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K240877Monteris Medical NeuroBlate SystemJune 4, 2024
K231061NeuroBlate SystemDecember 8, 2023
K222983NeuroBlate Fusion-S Software V3.17March 15, 2023
K201056NeuroBlate SystemAugust 21, 2020
K193375NeuroBlate SystemJanuary 3, 2020
K182036NeuroBlate SystemOctober 15, 2018
K173305NeuroBlate SystemNovember 17, 2017
K172881NeuroBlate SystemOctober 20, 2017
K171255Monteris Medical NeuroBlate SystemJuly 25, 2017
K170724NeuroBlate SystemApril 7, 2017
K162762NeuroBlate SystemOctober 26, 2016
K143457NeuroBlate SystemFebruary 19, 2015
K141983NEUROBLATE SYSTEMAugust 11, 2014
K132444ATAMA SYSTEMJanuary 27, 2014
K131955NEUROBLATE(TM) SYSTEMJuly 30, 2013
K131278MONTERIS MEDICAL NEUROBLATE SYSTEMJuly 11, 2013
K120561NEUROBLATE SYSTEMApril 1, 2013
K110411ATAMA SYSTEMApril 8, 2011
K090240MONTERIS MEDICAL UFOAugust 6, 2009
K081509MONTERIS MEDICAL AUTOLITT LASER PROBEMay 1, 2009