# K060419: Concerto Bipolar Needle Electrode

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 13, 2006 after 24 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ConcertoTM Bipolar Needle Electrode: named in the summary without a submission number

## Most influential descendants
- K070711: Incircle BI-Polar RF Ablation System (2007), 3 descendants of its own
- 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
ConcertoTM Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Source page: https://510kreport.com/device/K060419
Methodology: https://510kreport.com/methodology