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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrosurgical, active, urological
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeFAS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHIRURGIE INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA INC (DMTA)
  SUBSTANTIALLY EQUIVALENT 1
DORNIER MEDTECH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAMIDEY NOURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MULTI4 MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Olympus Corporation of the Americas II Dec-15-2023
3 Olympus Corporation of the Americas II Aug-17-2023
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