# K203150: Cool-tip RF Ablation System E Series

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Feb 25, 2022 after 491 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: 7 generations back to K870028 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 4.
- K070446: Cool-Tip Switching Controller, CTSW Control, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 4.

## Indications for use
The Cool-tip RF Ablation System E Series (generator, pump, patient return electrodes, water container, active electrodes, footswitch, and accessories) is intended for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, including partial or complete ablation of non-resectable liver tumors.

Source page: https://510kreport.com/device/K203150
Methodology: https://510kreport.com/methodology