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 |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
Submission Type |
510(k)
|
Regulation Number |
878.4400
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|