Electrosurgical Patient Return Electrode

What Is This Device?

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.

How Is ODR Classified?

Electrosurgical Patient Return Electrode is FDA product code ODR, Class 2, 21 CFR 878.4400.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 192 days from receipt to decision.