# K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab
- Decided: Mar 15, 2006 after 110 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: 5 generations back to K870028 (1987). 16 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042216: Cool-Tip RF Ablation System, Valleylab (2004) Summary page 1.

## Most influential descendants
- 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
- K133821: Emprint Ablation System (2014), 29 descendants of its own
- K163105: Emprint Ablation System (2016), 13 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 tumors.

Source page: https://510kreport.com/device/K053290
Methodology: https://510kreport.com/methodology