# K113265: Genii GI 4000 Electrosugical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Genii, Inc.
- Decided: Mar 22, 2012 after 139 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: 3 generations back to K894762 (1989). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073207: Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167, Celon AG Medical Instruments (2008) Summary page 2.
- K963189: Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories, Erbe USA, Inc. (1996) Summary page 2.
- K933157: Erbotom Icc 200, Erbe USA, Inc. (1994) Summary page 3.
- K013348: Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155, 20132-156, 20132-157, 20132-166, Erbe USA, Inc. (2001) Summary page 5.

## Most influential descendants
- K250657: gi2000 Electrosurgical Generator (2025), 0 descendants of its own

## Indications for use
The gi4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope waterjet channels, or endloscope working channels. The Genii ArConnect" Conducting Adapter is intended for use with the gi4000 during argon assisted coagulation.

Source page: https://510kreport.com/device/K113265
Methodology: https://510kreport.com/methodology