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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cooperative powered surgical assist device for ent surgery
Definition A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeon’s direct physical control of the instrument.
Product CodeQXG
Regulation Number 874.4460
Device Class 2


Premarket Reviews
ManufacturerDecision
GALEN ROBOTICS
  GRANTED 1

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