# K222425: Ellusa Reusable Neutral Plates

- Pathway: 510(k) (Special)
- Applicant: Ellusa, LLC
- Decided: Sep 8, 2022 after 28 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: 8 generations back to K933157 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202562: Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set, Ellusa, LLC (2020) Summary page 4.

## Indications for use
The Ellusa Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.

Source page: https://510kreport.com/device/K222425
Methodology: https://510kreport.com/methodology