ClearPoint System

Neurological Stereotaxic Instrument

ClearPoint Neuro, Inc.

The following data is part of a premarket notification filed by Clearpoint Neuro, Inc. with the FDA for Clearpoint System.

Pre-market Notification Details

Device IDK222519
510k NumberK222519
Device Name:ClearPoint System
ClassificationNeurological Stereotaxic Instrument
Applicant ClearPoint Neuro, Inc. 5 Musick Irvine,  CA  92618
ContactMary McNamara-Cullinane
CorrespondentJohn J Smith
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-19
Decision Date2022-09-16

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