NeuroBlate System

Powered Laser Surgical Instrument

Monteris Medical, Inc.

The following data is part of a premarket notification filed by Monteris Medical, Inc. with the FDA for Neuroblate System.

Pre-market Notification Details

Device IDK201056
510k NumberK201056
Device Name:NeuroBlate System
ClassificationPowered Laser Surgical Instrument
Applicant Monteris Medical, Inc. 14755 27th Avenue North; Suite C Plymouth,  MN  55447
ContactDavid H. Mueller
CorrespondentDavid H. Mueller
Monteris Medical, Inc. 14755 27th Avenue North; Suite C Plymouth,  MN  55447
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2020-08-21

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