# K113310: Endogater Avantage CO2 Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Byrne Medical, Inc.
- Decided: Jun 20, 2012 after 225 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K053008 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053008: E-Z-EM Endoscopic CO2 Regulator, E-Z-Em, Inc. (2005) Summary page 1.

## Indications for use
The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Source page: https://510kreport.com/device/K113310
Methodology: https://510kreport.com/methodology