# K030967: Rita Starburst Sde Electrosurgical Device

- Pathway: 510(k) (Special)
- Applicant: Rita Medical Systems
- Decided: Apr 21, 2003 after 26 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 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 90/StarBurst Electrosurgical Device: named in the summary without a submission number

## Most influential descendants
- K080451: Uniblate Electrosurgical Device (2008), 8 descendants of its own
- K161949: OsteoCool V-3 RF Ablation System (2017), 7 descendants of its own
- K182497: OsteoCool RF Ablation System (2019), 5 descendants of its own
- K221074: OptaBlate RF Generator, OptaBlate  Probes, OptaBlate Microinfuser Infusion Device (2022), 2 descendants of its own
- K233830: OsteoCool™ 2.0 RF Ablation System (2024), 1 descendant of its own

## Indications for use
The RITA@ StarBurst SDE Electrosurgical Device is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) 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 on 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 therapy.

Source page: https://510kreport.com/device/K030967
Methodology: https://510kreport.com/methodology