# K130483: Boehringer Gastric Sizing Tube

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Laboratories, LLC
- Decided: Mar 28, 2013 after 31 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: 2 generations back to K002838 (2001). 3 ancestors in all.
15 later devices descend from it; 8 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360, Obtech Medical Sarl (2007) Summary page 1.
- K110529: Endoflip Gastric Tube, Crospon, Ltd. (2011) Summary page 1.

## Most influential descendants
- 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
- K222880: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (2023), 1 descendant of its own

## Indications for use
The Boehringer Laboratories Gastric Sizing Tube is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Source page: https://510kreport.com/device/K130483
Methodology: https://510kreport.com/methodology