# K070446: Cool-Tip Switching Controller, CTSW Control

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab,A Division of Tyco Healthcare Group LP
- Decided: May 2, 2007 after 76 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: 6 generations back to K870028 (1987). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973297: Cosman Coagulator (CC-1) System, Radionics, Inc. (1997) Summary page 1.
- K984552: Cool-Tip RF System, Radionics, Inc. (1999) Summary page 1.
- K042216: Cool-Tip RF Ablation System, Valleylab (2004) Summary page 1.
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.

## Most influential descendants
- K203150: Cool-tip RF Ablation System E Series (2022), 0 descendants of its own
- K192715: CRF Radiofrequency Ablation System (2020), 0 descendants of its own

## Indications for use
The Cool-tipTM RF Switching Controller is to be used with the Cool-tipTM RF System and is intended for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as the partial or complete ablation of non-resectable liver tumors, and osteoid osteoma tumors within bone.

Source page: https://510kreport.com/device/K070446
Methodology: https://510kreport.com/methodology