# K982556: Leveen Needle Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Radiotherapeutics Corp.
- Decided: Apr 6, 2000 after 624 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K092009: Modification to: Leveen Superslim Needle Electrodes, Models M001262260, M001262270, M001262280, M001262290 (2009), 1 descendant of its own
- K113090: Leveen Superslim Needle Electrode (2012), 0 descendants of its own

## Recalls of this device
- Sep 17, 2012 · Class II · Z-0079-2013: Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-K
- Apr 30, 2008 · Not classified · Z-1916-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Apr 30, 2008 · Not classified · Z-1913-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Apr 30, 2008 · Not classified · Z-1914-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Apr 30, 2008 · Not classified · Z-1915-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Oct 1, 2007 · Not classified · Z-2093-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Oct 1, 2007 · Not classified · Z-2094-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Oct 1, 2007 · Not classified · Z-2091-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Oct 1, 2007 · Not classified · Z-2092-2008: The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
- Jul 29, 2005 · Not classified · Z-1542-05: Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
- Jul 29, 2005 · Not classified · Z-1541-05: Firm has received complaints of extended ablation times, lack of roll-off and patient burns.

## Indications for use
The LeVeen Needle Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation 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/K982556
Methodology: https://510kreport.com/methodology