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U.S. Department of Health and Human Services

Product Classification

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Device table mounted miniaturized electromechanical surgical system
Definition A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms
Physical State The device is compact robot which operated via a surgeon console. The electromechanical system has an shoulder, elbow, wrist configuration, which mimics human motion at the shoulder and elbow level but only rotates at the wrist. The console is open format and allows the surgeon to sit at the necessary height to comfortable control and monitor the device.
Technical Method Is a table mounted, teleoperated device with two arms which can grasp, retract, and dissect tissue. The device is suspended above the patient and positioned intra-abdominally to mobilize tissue.
Target Area Intra-abdominal, colon
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeSAB
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4962
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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