# K010060: Rita Starburst Xli Electrosurgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Rita Medical Systems
- Decided: Jan 23, 2001 after 15 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070101: Uniblate Electrosurgical Device (2007), 22 descendants of its own
- K080376: Oncobionic System (2008), 11 descendants of its own
- K102329: Nanoknife System (2011), 10 descendants of its own
- K150089: NanoKnife System (2015), 8 descendants of its own
- K080451: Uniblate Electrosurgical Device (2008), 8 descendants of its own

## Recalls of this device
- Oct 2, 2019 · Class II · Z-0411-2020: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
- May 2, 2006 · Not classified · Z-0887-06: Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
- May 2, 2006 · Not classified · Z-0888-06: Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker

Source page: https://510kreport.com/device/K010060
Methodology: https://510kreport.com/methodology