Product code ODR

Device name

Electrosurgical Patient Return Electrode

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4400

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset