# K081954: Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector Cable

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jul 31, 2008 after 22 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: 10 generations back to K936109 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050550: Gyrus General Purpose Electrosurgical Generator, Gyrus Medical, Inc. (2005) Summary page 1.

## 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/K081954
Methodology: https://510kreport.com/methodology