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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 K212736
Device Name Canady Flex RoboWrist
Applicant
Us Medical Innovations, LLC
6930 Carroll Ave., Suite 1000
Takoma Park,  MD  20912
Applicant Contact Jerome Canady
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Michael A. Siano
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
GEI  
Date Received08/30/2021
Decision Date 11/22/2022
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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