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