# K243067: The ETHICON™ Total Energy System

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company)
- Decided: Jan 17, 2025 after 112 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K932293 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200841: Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11, Ethicon Endo-Surgery, LLC (2020) Summary page 9.
- K193145: Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch, Megadyne Medical Products, Inc. (2020) Summary page 9.

## 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.

Source page: https://510kreport.com/device/K243067
Methodology: https://510kreport.com/methodology