# K070711: Incircle BI-Polar RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Rfa Medical, Inc.
- Decided: Apr 24, 2007 after 41 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: 1 generation back to K010060 (2001). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040785: Concerto Bipolar Needle Electrode, Boston Scientific Corp (2004) Summary page 2.
- K050361: Modification to Concerto Bipolar Needle Electrode, Boston Scientific Corp (2005) Summary page 2.
- K060419: Concerto Bipolar Needle Electrode, Boston Scientific Corp (2006) Summary page 2.
- K010060: Rita Starburst Xli Electrosurgical Device, Rita Medical Systems (2001) Summary page 2.

## Most influential descendants
- K070443: Intracept BI-Polar RF Probe, Model 04814 (2007), 2 descendants of its own
- K083856: Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026 (2009), 0 descendants of its own
- K082954: Encage Bipolar RF Probe (2008), 0 descendants of its own

## Indications for use
The RFA Medical InCircleTM Bi-Polar RF Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Source page: https://510kreport.com/device/K070711
Methodology: https://510kreport.com/methodology