# K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Jul 21, 2003 after 108 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: 1 generation back to K001270 (2000). 3 ancestors in all.
57 later devices descend from it; 7 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003060: Plasmakinetic Generator, Everest Medical Corp. (2000) Summary page 1.
- K003569: Plasmakinetic Endourology System, Gyrus Medical, Ltd. (2000) Summary page 1.
- K001270: Gyrus Endourology System: Axipolar Resectoscope Loop Electrode, Gyrus Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K082054: Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch Connector Cable, Model 710003 (2008), 23 descendants of its own
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), 22 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), 15 descendants of its own
- K050550: Gyrus General Purpose Electrosurgical Generator (2005), 14 descendants of its own

## Indications for use
The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K031085
Methodology: https://510kreport.com/methodology