# K181758: ELRA Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Starmed Co., Ltd.
- Decided: Apr 11, 2019 after 283 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K970278 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180165: Habib EndoHPB, Emcision, Ltd. (2018) Summary page 4.

## Most influential descendants
- K233113: ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (2023), 0 descendants of its own

## Indications for use
The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

Source page: https://510kreport.com/device/K181758
Methodology: https://510kreport.com/methodology