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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K252790
Device Name Digital ClarusScope System and Digital NeuroPEN System
Applicant
Clarus Medical, LLC
13355 10th Ave. N.
Minneapolis,  MN  55441
Applicant Contact Mark Brown
Correspondent
Alan Vanhouten Biomedical Consultant
916 Ridgecrest Dr.
Carver,  MN  55315
Correspondent Contact Alan VanHouten
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/02/2025
Decision Date 05/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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