# K202558: Ellusa Bipolar Wands

- 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: 6 generations back to K954171 (1996). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190336: Soniquence Bipolar Electrodes, Soniquence, LLC (2019) Summary page 5.

## Most influential descendants
- K222429: Ellusa Reusable Bipolar Cable (2022), 0 descendants of its own

## Indications for use
The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.

Source page: https://510kreport.com/device/K202558
Methodology: https://510kreport.com/methodology