# K012785: Twintrode Elc 134 Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Healthtronics Surgical Services, Inc.
- Decided: Nov 16, 2001 after 88 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NewTrode® ELC 124 Electrode: named in the summary without a submission number

## Indications for use
The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.

Source page: https://510kreport.com/device/K012785
Methodology: https://510kreport.com/methodology