# K082954: Encage Bipolar RF Probe

- Pathway: 510(k) (Traditional)
- Applicant: Trod Medical SA
- Decided: Oct 17, 2008 after 14 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 K942299 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070711: Incircle BI-Polar RF Ablation System, Rfa Medical, Inc. (2007) Summary page 1.
- K070443: Intracept BI-Polar RF Probe, Model 04814, Relievant Medsystems, Inc. (2007) Summary page 1.
- K011722: Atricure Bipolar Coagulation System, AtriCure, Inc. (2001)
- K030967: Rita Starburst Sde Electrosurgical Device, Rita Medical Systems (2003) Summary page 1.

## Indications for use
The ENCAGE bipolar RF probe is intended to be used in conjunction with radiofrequency (RF) generators for percutaneous, laparoscopic, or intraoperative thermal coagulation of soft tissues.

Source page: https://510kreport.com/device/K082954
Methodology: https://510kreport.com/methodology