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The ETHICON™ Total Energy System

Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)

Country / Region:United States (US)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Product code

GEI
21 CFR 878.4400

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243067
Device name
The ETHICON™ Total Energy System
Country / Region
United States(US)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2024-09-27
Decision date
2025-01-17
Submission type
Traditional
Technology type
RF Generator(AI inferred)
Clinical applications
Surgery
Primary application
Surgery
Classification source
AI classified

Indications for Use

The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

Intended Use

The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.

Device Description

The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360º mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total E

Summary parsed at:2026-06-20 17:45:46 UTC

Predicate devices

2

K243067 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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