# K113090: Leveen Superslim Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Mar 15, 2012 after 148 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: 2 generations back to K000032 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092009: Modification to: Leveen Superslim Needle Electrodes, Models M001262260, M001262270, M001262280, M001262290, Boston Scientific Corporation (2009) Summary page 2.

## Indications for use
The LeVeen SuperSlim Needle Electrode is intended to be used in conjunction with a 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/K113090
Methodology: https://510kreport.com/methodology