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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 K252020
Device Name TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
Applicant
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Applicant Contact Egypt Brown
Correspondent
Hand Biomechanics Lab, Inc.
77 Scripps Dr., Suite 104
Sacramento,  CA  95825
Correspondent Contact Egypt Brown
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Codes
EMF   KCT  
Date Received06/30/2025
Decision Date 10/15/2025
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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