# K050550: Gyrus General Purpose Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Nov 9, 2005 after 251 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: 9 generations back to K936109 (1994). 69 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Medical, Ltd. (2004) Summary page 1.
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003) Summary page 1.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 1.

## Most influential descendants
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), 3 descendants of its own
- K100896: Gyrus Acmi Halo PKS Cutting Forceps (2010), 3 descendants of its own
- K081766: PKS Omni Instrument (2008), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own
- K142759: PK Cutting Forceps for ESG-400 Workstation (2015), 2 descendants of its own

## Indications for use
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

Source page: https://510kreport.com/device/K050550
Methodology: https://510kreport.com/methodology