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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
Product CodeSAB
Regulation Number 878.4962
Device Class 2


Premarket Reviews
ManufacturerDecision
VIRTUAL INCISION
  GRANTED 1

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