# K042216: Cool-Tip RF Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Nov 12, 2004 after 88 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: 4 generations back to K870028 (1987). 15 ancestors in all.
75 later devices descend from it; 6 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984552: Cool-Tip RF System, Radionics, Inc. (1999) Summary page 1.
- K993944: Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive Electrode, Rita Medical Systems (1999) Summary page 1.
- K021329: Rita System, Rita Medical Systems (2002) Summary page 1.
- K031257: Rita Model 1500X Electrosurgical RF Generator, Rita Medical Systems, Inc. (2003) Summary page 1.
- K031926: Rita Model 1500X Electrosurgical RF Generator and Accessories (E.G., Rita Thermo Pad and Cable Adapter), Rita Medical Systems, Inc. (2003) Summary page 1.
- K012315: Leveen Electrode, Radiotherapeutics Corp. (2001) Summary page 1.
- K000241: Radiotherapeutics RF 3000 Radiofrequency Generator, Radiotherapeutics Corp. (2000) Summary page 1.

## Most influential descendants
- 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
- K113237: Certus 140 2.45GHZ Ablation System (2012), 38 descendants of its own

## Indications for use
The Cool-tipTM RF Ablation System (Generator and Accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions.

Source page: https://510kreport.com/device/K042216
Methodology: https://510kreport.com/methodology