Product Classification

• 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 Code: SCV
• Premarket Review: General Surgery Devices (DHT4A); 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

Recognized Consensus Standard

• 6-510 IEC 80601-2-77 Edition 1.1 2023-11 CONSOLIDATED VERSION
  Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT

Third Party Review

Not Third Party Eligible