# K250657: gi2000 Electrosurgical Generator

- Pathway: 510(k) (Traditional)
- Applicant: Cintron Medical Corporation
- Decided: Jun 3, 2025 after 90 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: 4 generations back to K894762 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113265: Genii GI 4000 Electrosugical Generator, Genii, Inc. (2012) Summary page 5.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 5.

## Indications for use
The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.

Source page: https://510kreport.com/device/K250657
Methodology: https://510kreport.com/methodology