# K190336: Soniquence Bipolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Soniquence, LLC
- Decided: Jun 20, 2019 after 126 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: 5 generations back to K954171 (1996). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130110: Meddusa Bipolar System, Elliquence, LLC (2013) Summary page 5.
- K003126: Bipolar Trigger-Flex Probe, Ellman Intl., Inc. (2001) Summary page 5.

## Most influential descendants
- K202558: Ellusa Bipolar Wands (2020), 1 descendant of its own
- K222429: Ellusa Reusable Bipolar Cable (2022), 0 descendants of its own
- K211946: Soniquence Reusable Bipolar Cable (2021), 0 descendants of its own

## Indications for use
The Soniquence Bipolar Electrode is 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/K190336
Methodology: https://510kreport.com/methodology