# K140495: Leveen Standard Needle Electrode, Leveen Coaccess Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 17, 2014 after 49 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 K992556 (2000). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 1.
- K012315: Leveen Electrode, Radiotherapeutics Corp. (2001) Summary page 1.

## Most influential descendants
- K150029: Habib EUS RFA (2015), 5 descendants of its own
- K181249: EUSRA RF Electrode (2018), 2 descendants of its own
- K240932: HybridTherm System (2024), 1 descendant of its own
- K161305: Habib EUS RFA (2016), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Indications for use
The LeVeenTM Needle Electrode Family (which includes the LeVeenTM Standard Needle Electrode System and the LeVeenTM CoAccessTM Needle Electrode System) is intended to be used in conjunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Source page: https://510kreport.com/device/K140495
Methodology: https://510kreport.com/methodology