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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device integrated operating table-electromechanical surgical system
Definition An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.
Product CodeSIR
Regulation Number 878.4966
Device Class 2


Premarket Reviews
ManufacturerDecision
AURIS HEALTH, INC., PART OF JOHNSON & JOHNSON MEDTECH
  GRANTED 1

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