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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 wherein the surgeon annd the user interface can be in the sterile field
Definition An electromechanical surgical system with transient sterile field presence of both surgeon and primary control interface is a software-controlled electromechanical system with fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures. The device allows for both the surgeon and primary control interface to have presence inside the sterile field as needed within the clinical context of use.
Product CodeSDD
Regulation Number 878.4965
Device Class 2


Premarket Reviews
ManufacturerDecision
DISTALMOTION SA
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 2 2
Therapy Delivered to Incorrect Body Area 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Burn(s) 1 1

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