# K120567: Gyrus Amci PK Button Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jun 20, 2012 after 114 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- 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: 6 generations back to K911904 (1991). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093181: Gyrus Acmi PK Button Electrode, Gyrus Acmi, Inc. (2010) Summary page 2.
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands, Olympus Winter & Ibe GmbH (2011) Summary page 2.
- K100816: PK Superpulse Sysem Generator Model 744000, Gyrus Acmi, Inc. (2010) Summary page 2.

## Most influential descendants
- K163090: Plasma Edge System (2017), 2 descendants of its own
- K213135: Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (2022), 1 descendant of its own
- K240504: PLASMA EDGE System (2024), 0 descendants of its own

## Indications for use
The Gyrus AGMI PK® Button Electrode is a bipolar instrument intended for use in urological electrosurgical procedures involving the ablation or removal of soft tissue and where associated hemnostasis is required. The specific urological indication fdr the PK@ Button device is Transurethral Vaporization of the prostate (TIJVP/TVP) fdr benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. The PK&~ Button is not to be used to resect tissue.

Source page: https://510kreport.com/device/K120567
Methodology: https://510kreport.com/methodology