MindsEye Expandable Port

Retractor, Self-retaining, For Neurosurgery

Minnetronix Neuro, INC.

The following data is part of a premarket notification filed by Minnetronix Neuro, Inc. with the FDA for Mindseye Expandable Port.

Pre-market Notification Details

Device IDK202072
510k NumberK202072
Device Name:MindsEye Expandable Port
ClassificationRetractor, Self-retaining, For Neurosurgery
Applicant Minnetronix Neuro, INC. 1635 Energy Park Drive St. Paul,  MN  55108
ContactMatt Adams
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGZT  
CFR Regulation Number882.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-07-27
Decision Date2020-08-26

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