ODR — Electrosurgical Patient Return Electrode Class II

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160366top-rank health care coElectrosurgical disposable grounding padsAugust 19, 2016
K121268bio-med usaWANDY DISPERSVIE ELECTRODEDecember 20, 2012
K082204ventlabSERIES SY DISPOSABLE ELECTROSURGICAL PADAugust 13, 2008