# K183611: Soniquence RF Generator and Soniquence Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Soniquence, LLC
- Decided: May 22, 2019 after 147 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 K933157 (1994). 32 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170107: Surgi Max Ultra, Elliquence, LLC (2017) Summary page 5.
- K134054: Bovie Ids-310 High Frequency Electrosurgical Generator, Aaron A3350 High Frequency Electrosurgical Generator, Bovie Medical Corporation (2014) Summary page 5.
- K142410: Elliquence Electrodes, Elliquence, LLC (2015) Summary page 5.
- K160041: Cobbra RF Tissue Dissector, Elliquence, LLC (2016) Summary page 5.

## Most influential descendants
- K212222: Soniquence Reusable 3 Button Fingerswitch Wand (2022), 1 descendant of its own
- K202562: Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set (2020), 1 descendant of its own
- K254220: Reusable 3 Button Fingerswitch Wand (2026), 0 descendants of its own
- K222425: Ellusa Reusable Neutral Plates (2022), 0 descendants of its own
- K220071: Soniquence Reusable Neutral Plate (2022), 0 descendants of its own

## Indications for use
The Soniquence RF 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 Soniquence Electrodes 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/K183611
Methodology: https://510kreport.com/methodology