# K093181: Gyrus Acmi PK Button Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Feb 24, 2010 after 139 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: 2 generations back to K933002 (1994). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003) Summary page 2.
- K990628: Gyrus Endourology System, Gyrus Medical, Ltd. (1999) Summary page 2.
- K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode, Circon Corp. (1998) Summary page 2.
- K903323: Resectoscope Loops, Olympus Corp. (1990) Summary page 2.

## Most influential descendants
- K120567: Gyrus Amci PK Button Electrode (2012), 3 descendants of its own
- 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 ACMI PK® Button Electrode is a bipolar instrument intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indication for the PK® Button is transurethral electrovaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy only. The PK® Button is not to be used to resect tissue.

Source page: https://510kreport.com/device/K093181
Methodology: https://510kreport.com/methodology