ODR

Electrosurgical Patient Return Electrode

Product code
ODR
Device name
Electrosurgical Patient Return Electrode
Device class
Class 2
21 CFR
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: ODR
Classification and pathway per current FDA publications. Data from openFDA (CC0).