# K984552: Cool-Tip RF System

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Mar 5, 1999 after 73 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,174 later devices descend from it; 12 cite it directly.
0 of 1,175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K000944: Thermage Thermacool System (2000), 1,069 descendants of its own
- K013034: Modification to: Thermacool Iia (2001), 800 descendants of its own
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own

## Recalls of this device
- Apr 21, 2006 · Not classified · Z-0859-06: Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.

## Indications for use
The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.

Source page: https://510kreport.com/device/K984552
Methodology: https://510kreport.com/methodology