# K202562: Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set

- Pathway: 510(k) (Traditional)
- Applicant: Ellusa, LLC
- Decided: Nov 2, 2020 after 59 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: 7 generations back to K933157 (1994). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183611: Soniquence RF Generator and Soniquence Electrodes, Soniquence, LLC (2019) Summary page 5.

## Most influential descendants
- K222425: Ellusa Reusable Neutral Plates (2022), 0 descendants of its own

## Indications for use
The Ellusa Generator is intended to provide high frequency energy for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels during surgical procedures and is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. The Ellusa Monopolar Tips are intended for use by a physician familiar with resection, dissection, incision, and hemostasis in soft tissue surgical procedures.

Source page: https://510kreport.com/device/K202562
Methodology: https://510kreport.com/methodology