# K012315: Leveen Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Radiotherapeutics Corp.
- Decided: Oct 11, 2001 after 80 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
81 later devices descend from it; 2 cite it directly.
0 of 82 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) LeVeen™ Electrode: named in the summary without a submission number

## Most influential descendants
- K042216: Cool-Tip RF Ablation System (2004), 75 descendants of its own
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 56 descendants of its own
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 50 descendants of its own
- K072687: Valleylab Microwave Ablation Generator (2008), 42 descendants of its own
- K100744: Certus 140 Microwave Ablation System and Accessories, Model Certus 140 (2010), 39 descendants of its own

## Recalls of this device
- Sep 17, 2012 · Class II · Z-0081-2013: 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
- Sep 17, 2012 · Class II · Z-0080-2013: 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

## Indications for use
The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.

Source page: https://510kreport.com/device/K012315
Methodology: https://510kreport.com/methodology