# K122716: Plasmatrode Saline Safe Tur Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: Apr 17, 2013 after 224 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 K911904 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935874: Cook Coagulator Probe, Cook Urological, Inc. (1994) Summary page 1.
- K990628: Gyrus Endourology System, Gyrus Medical, Ltd. (1999) Summary page 1.
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands, Olympus Winter & Ibe GmbH (2010) Summary page 1.
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands, Olympus Winter & Ibe GmbH (2011) Summary page 1.

## Indications for use
This device is used to vaporize and coagulate soft prostatic tissue during the treatment of Benign Prostatic Hyperplasia and for use with a compatible resectoscope.

Source page: https://510kreport.com/device/K122716
Methodology: https://510kreport.com/methodology