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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, ablation, ultrasound and accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.
Product CodeNTB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
EPICOR MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 2
Total Device Problems 2

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