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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K260183
Device Name MediBot Needle Driver Uno
Applicant
Parallel Robotics, LLC
3810 Packard St., Suite 100a
Ann Arbor,  MI  48108
Applicant Contact Russell Jahnke
Correspondent
Parallel Robotics, LLC
3810 Packard St., Suite 100a
Ann Arbor,  MI  48108
Correspondent Contact Russell Jahnke
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/21/2026
Decision Date 05/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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