# K211946: Soniquence Reusable Bipolar Cable

- Pathway: 510(k) (Special)
- Applicant: Soniquence, LLC
- Decided: Jul 16, 2021 after 23 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). 12 ancestors in all.
No later device cites it as a predicate yet.
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.
- K042608: Tecno Reusable Bipolar Cables, Model 190-100 and 190-110, Tecno Instruments (Pvt.), Ltd. (2004) Summary page 5.

## Indications for use
The Soniquence Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.

Source page: https://510kreport.com/device/K211946
Methodology: https://510kreport.com/methodology