Electrosurgical Patient Return Electrode

ODR · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4400

Classification

FDA Product Code: ODR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4400
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 11

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown