Product Classification

Device

electrosurgical patient return electrode

Regulation Description

Electrosurgical cutting and coagulation device and accessories.

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.

Physical State

The electrode consists of five distinct layers of materials: the Mylar (protective cover) which is removed prior to use, Gel, Aluminum, Acrylic Adhesive and Blue Foam. The electrode construction consists of a dual aluminum electrode which connects to the generator during surgery. The aluminum is backed with a blue polyethylene foam pad with an acrylic adhesive which prevent fluid ingress. The aluminum is covered with a conductive Hydrogel adhesive. The aluminum and the Hydrogel are the conductive layers.

Technical Method

Electrosurgical Patient Return Electrode is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an patient. It is furnished with a cord. The pad has a hydrogel adhesive for conductivity with an acrylic border to prevent invasion of fluids. Both pad designs are compatible with return electrode monitoring generator systems.

Target Area

Thigh

Regulation Medical Specialty

General & Plastic Surgery

Review Panel

General & Plastic Surgery

Product Code

ODR

Premarket Review

General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)

Submission Type

510(k)