# K120126: Barosense Endogastric Tube and Introducer Bougie

- Pathway: 510(k) (Special)
- Applicant: Barosense, Inc.
- Decided: Sep 10, 2012 after 237 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- 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: 3 generations back to K942044 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082589: Barosense Endogastric Tube (Egt), Model F0034, Barosense, Inc. (2009) Summary page 2.

## Indications for use
The BaroSense Endogastric Tube (BUT) is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.

Source page: https://510kreport.com/device/K120126
Methodology: https://510kreport.com/methodology