ClearPoint Array 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 Array System.

Pre-market Notification Details

Device IDK202575
510k NumberK202575
Device Name:ClearPoint Array System
ClassificationNeurological Stereotaxic Instrument
Applicant ClearPoint Neuro, Inc. 5 Musick Irvine,  CA  92618
ContactPete Piferi
CorrespondentJohn Smith
Hogan Lovells US LLP 555 Thirteenth St. NW Washington,  DC  20004
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-04
Decision Date2021-01-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850376007611 K202575 000
00850376007598 K202575 000
00850376007604 K202575 000
00850376007628 K202575 000
00850376007635 K202575 000
00850359007744 K202575 000
00850359007904 K202575 000
00850359007911 K202575 000
00850359007928 K202575 000
00850359007935 K202575 000
00850376007710 K202575 000

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