# K913281: E-Z Clean Laparoscopic Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Aug 16, 1991 after 23 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris) (2004), 11 descendants of its own
- 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
- K153265: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated (2016), 3 descendants of its own

## Recalls of this device
- Aug 7, 2013 · Class II · Z-2097-2013: Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.

Source page: https://510kreport.com/device/K913281
Methodology: https://510kreport.com/methodology