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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electromechanical surgical system for endoluminal surgical procedures
Definition An electromechanical surgical system for endoluminal surgical procedures is a software-controlled electromechanical system with human/device interfaces that allows a qualified user to perform surgical procedures using robotically-controlled instruments passed through an endoscope into a body lumen.
Product CodeSJS
Regulation Number 878.4967
Device Class 2


Premarket Reviews
ManufacturerDecision
VIRTUOSO SURGICAL, INC.
  GRANTED 1

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