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U.S. Department of Health and Human Services

Product Classification
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Device modular electromechanical surgical system
Definition A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.
Physical State The device contains a surgeon console, a plurality of bedside units which include robotic arms, and associated instruments and accessories.
Technical Method The device utilizes electromechanical arms with laparoscopic instruments that are controlled by a qualified surgeon to manipulate structures in the human body.
Target Area Torso
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeSCV
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4964
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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