# K233113: ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)

- Pathway: 510(k) (Special)
- Applicant: Starmed Co., Ltd.
- Decided: Oct 25, 2023 after 28 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: 5 generations back to K970278 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181758: ELRA Electrode, Starmed Co., Ltd. (2019) Summary page 5.

## 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/K233113
Methodology: https://510kreport.com/methodology