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U.S. Department of Health and Human Services

Product Classification

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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 CodeODR
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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons