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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K223615
Device Name Digital ClarusScope System, Digital NeuroPEN System
Applicant
Clarus Medical, LLC
13355 10th Ave N Suite 110
Plymouth,  MN  55441
Applicant Contact Mark F. Brown
Correspondent
Clarus Medical, LLC
13355 10th Ave N Suite 110
Plymouth,  MN  55441
Correspondent Contact Mark F. Brown
Regulation Number882.1480
Classification Product Code
GWG  
Date Received12/05/2022
Decision Date 11/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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