DeviceClearance

Product code ODR— General, Plastic Surgery

Electrosurgical disposable grounding pads

Classification name
Electrosurgical Patient Return Electrode
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ODR under 21 CFR 878.4400, via openFDA

Market context for product code ODR

FDA has cleared 3 devices under product code ODR between 2008 and 2016, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ODR

Recent clearances under product code ODR

Data sourced from openFDA. This site is unofficial and independent of the FDA.