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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical patient return electrode
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Product CodeODR
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 24
Burn of device or device component 9
Loose 8
Device displays error message 4
Overheating of device or device component 3
Arcing 1
Misapplication 1
Normal 1
Material discolored 1
Total Device Problems 52

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