# K983214: Rita RF Generator and Accessories, Model 500 Series

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems
- Decided: Mar 27, 2000 after 560 days
- Product code: GXD (Generator, Lesion, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 882.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
79 later devices descend from it; 2 cite it directly.
0 of 80 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. — Model 500 Electrosurgical RF Generator: named in the summary without a submission number
- (no number) RITA Medical Systems Inc. — Models 20 and 30 Electrosurgical Accessories: named in the summary without a submission number
- (no number) RITA Medical Systems Inc. — Model 30F Electrosurgical Probe: named in the summary without a submission number
- (no number) RITA Medical Systems Inc. — Model 200C Electrosurgical Probe: named in the summary without a submission number
- (no number) RITA Medical Systems Inc. — Model 30-6 Electrode Array Electrosurgical Probe: named in the summary without a submission number
- (no number) RITA Medical Systems Inc. — Model 10P Passive Temperature Probe Accessory: named in the summary without a submission number

## Most influential descendants
- K021329: Rita System (2002), 76 descendants of its own
- K042216: Cool-Tip RF Ablation System (2004), 75 descendants of its own
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 56 descendants of its own
- K053290: Cool-Tip RF Generator, Cool-Tip RF System Accessories (2006), 50 descendants of its own
- K072687: Valleylab Microwave Ablation Generator (2008), 42 descendants of its own

## Indications for use
The RITA System (Model 500 RF Generator and Accessories) supplies energy for use in electrosurgery, and are 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.

Source page: https://510kreport.com/device/K983214
Methodology: https://510kreport.com/methodology