# K080451: Uniblate Electrosurgical Device

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jul 3, 2008 after 135 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
Longest line of descent: 6 generations back to K870028 (1987). 20 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070101: Uniblate Electrosurgical Device, Rita Medical Systems, Inc. (2007) Summary page 1.
- K030967: Rita Starburst Sde Electrosurgical Device, Rita Medical Systems (2003) Summary page 1.
- K052796: Cool-Tip RF Generator, Cool-Tip RF System Accessories, Valleylab (2006) Summary page 1.

## Most influential descendants
- 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
- K253656: OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (2026), 0 descendants of its own

## Indications for use
The AngioDynamics Uniblate Electrosurgical Device is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures such as partial or complete ablation of non-resectable liver lesions, osteoid osteoma, and 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/K080451
Methodology: https://510kreport.com/methodology