# K181249: EUSRA RF Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Sep 4, 2018 after 117 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: 4 generations back to K945531 (1995). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150029: Habib EUS RFA, Emcision, Ltd. (2015) Summary page 4.

## Most influential descendants
- K240932: HybridTherm System (2024), 1 descendant of its own
- K251108: Erbe ESU Model VIO® 3n with Accessories (2025), 0 descendants of its own

## Indications for use
The EUSRA RF Electrode is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.

Source page: https://510kreport.com/device/K181249
Methodology: https://510kreport.com/methodology