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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table Mounted Miniaturized Electromechanical Surgical System
510(k) Number K260817
Device Name MIRA Surgical System
Applicant
Virtual Incision
1501 Old Cheney Rd.
Lincoln,  NE  68512
Applicant Contact Florence Beck
Correspondent
Virtual Incision
1501 Old Cheney Rd.
Lincoln,  NE  68512
Correspondent Contact Florence Beck
Classification Product Code
SAB  
Date Received03/13/2026
Decision Date 08/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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