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Electrosurgical Infant Patient Return Electrode, Dual Plate With Cord, Model EP 211M

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071080

by E Surgical, LLC

Identifiers

510(k) Number
K071080 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Electrosurgical Infant Patient Return Electrode is a dispersive electrode designed to complete the electrosurgical circuit between the generator, the active electrode, and the infant patient. It features a dual plate design with a pre-attached cord and is intended to adhere to the patient over the entire pad surface during electrosurgical procedures.

This device is supplied as a single-use, non-sterile product. It has received FDA 510(k) clearance under the K071080 submission. Users should follow standard clinical protocols for the application and disposal of dispersive electrodes in a surgical setting.

Frequently asked questions

What is the intended use of the EP 211M return electrode?

This device is designed to function as a dispersive electrode during electrosurgical procedures. Its primary purpose is to complete the electrical circuit between the electrosurgical generator, the active electrode, and the infant patient.

Is this electrode intended for single-use or can it be reprocessed?

The EP 211M is supplied as a single-use device. It is intended to be applied to the patient for a procedure and then disposed of according to standard clinical protocols for surgical waste.

Is the Electrosurgical Infant Patient Return Electrode sterile?

No, this device is supplied as a non-sterile product. Users should adhere to standard clinical protocols for the application and handling of the electrode within the surgical environment.

What is the regulatory status of this device?

The device has received FDA 510(k) clearance under submission number K071080. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Electrosurgical Infant Patient Return Electrode, Dual Plate With Cord ..., E Surgical Electrosurgical Patient Return Electrode, Dual Plate With ..., E Surgical Electrosurgical Patient Return Electrode, Dual Plate With ..., E SURGICAL, LLC FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
E Surgical, LLC

Sources (1)

  • FDA 510(k) K071080 24 fields · synced Sep 25, 2026