ODR — Electrosurgical Patient Return Electrode Class II
FDA product code ODR covers "Electrosurgical Patient Return Electrode", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ODR
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.