# K193145: Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Mar 24, 2020 after 132 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: 2 generations back to K944602 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050579: Mega Power Electrosurgical Generator, Megadyne Medical Products, Inc. (2005) Summary page 4.

## Most influential descendants
- K243067: The ETHICON™ Total Energy System (2025), 0 descendants of its own
- K213696: ETHICON Megadyne Electrosurgical Generator (2022), 0 descendants of its own

## Indications for use
The Ethicon Megadyne® Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Source page: https://510kreport.com/device/K193145
Methodology: https://510kreport.com/methodology