# K080287: Oncobionic Bipolar Electrode

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jul 3, 2008 after 150 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: 8 generations back to K942299 (1995). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060054: Oncobionic System, Oncobionics, Inc. (2006) Summary page 1.
- K070101: Uniblate Electrosurgical Device, Rita Medical Systems, Inc. (2007) Summary page 1.

## Indications for use
The Oncobobionic Bipolar Electrode is intended to be used only with the Oncobionic System and is indicated for surgical ablation of soft tissue.

Source page: https://510kreport.com/device/K080287
Methodology: https://510kreport.com/methodology