# K110529: Endoflip Gastric Tube

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Jul 22, 2011 after 148 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K002838 (2001). 1 ancestor in all.
16 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002838: Gastric Suction and Drainage Catheter, Bioenterics Corp. (2001) Summary page 1.

## Most influential descendants
- K130483: Boehringer Gastric Sizing Tube (2013), 15 descendants of its own
- K191885: Standard Bougie (2020), 3 descendants of its own
- K210437: Standard Bougie, 38 Fr. (2021), 2 descendants of its own
- K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (2024), 1 descendant of its own
- K234145: ViSiGi 3D Gastric Sizing Tube (2024), 1 descendant of its own

## Indications for use
The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and EF-325 catheters.

Source page: https://510kreport.com/device/K110529
Methodology: https://510kreport.com/methodology