# K040989: Rita Systems

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems
- Decided: Apr 28, 2004 after 12 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) RITA Medical Systems Inc. - RITA System: named in the summary without a submission number

## Most influential descendants
- K063172: Arthrocare Cavity Spinewand (2007), 12 descendants of its own
- K091310: Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 (2010), 11 descendants of its own
- K142480: OsteoCool V-2 RF Ablation System (2015), 9 descendants of its own
- K152057: OsteoCool V-3 RF Ablation System (2015), 8 descendants of its own
- K161949: OsteoCool V-3 RF Ablation System (2017), 7 descendants of its own

## Recalls of this device
- Jun 11, 2013 · Class II · Z-1675-2013: The RITA Main Cable product contains the incorrect Instructions for Use.

## Indications for use
The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: the partial or complete ablation of non-resectable liver lesions and the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

Source page: https://510kreport.com/device/K040989
Methodology: https://510kreport.com/methodology