# K082589: Barosense Endogastric Tube (Egt), Model F0034

- Pathway: 510(k) (Traditional)
- Applicant: Barosense, Inc.
- Decided: May 22, 2009 after 256 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: 2 generations back to K942044 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040836: Disposable Overtube, United States Endoscopy Group, Inc. (2004) Summary page 2.
- K002018: Ndo Surgical Surgical Overtube, Surgical, Inc. (2000) Summary page 2.
- K973500: Bard Endoscopic Overtube (#000307), C.R. Bard, Inc. (1997) Summary page 2.

## Most influential descendants
- K120126: Barosense Endogastric Tube and Introducer Bougie (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K082589
Methodology: https://510kreport.com/methodology