# K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris)

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Jun 4, 2004 after 79 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: 1 generation back to K913281 (1991). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913281: E-Z Clean Laparoscopic Electrode, Megadyne Medical Products, Inc. (1991) Summary page 2.
- K943055: Electrosurgical Cutting and Coagulating Device and Accessories, Megadyne Medical Products, Inc. (1994) Summary page 2.

## Most influential descendants
- K052759: Dan Monopolar Lap Accessories (2006), 8 descendants of its own
- K081503: Aed Monopolar Lap Accessories (2008), 7 descendants of its own
- K103508: Unmiax Laparoscopic Instrument (2011), 6 descendants of its own
- K142208: Monopolar Laparascopic Accessories (2015), 1 descendant of its own
- K060232: Trokamed GMBH Electrosurgical Instruments & Accessories (2006), 1 descendant of its own

## Indications for use
The Reusable Laparoscopic Electrodes are intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. The electrodes are reusable; they are intended to be cleaned, sterilized, and reused.

Source page: https://510kreport.com/device/K040699
Methodology: https://510kreport.com/methodology