# K234145: ViSiGi 3D Gastric Sizing Tube

- Pathway: 510(k) (Special)
- Applicant: Boehringer Laboratories
- Decided: Jan 26, 2024 after 28 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: 3 generations back to K002838 (2001). 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)
- K130483: Boehringer Gastric Sizing Tube, Boehringer Laboratories, LLC (2013) Summary page 5.

## Most influential descendants
- K261890: 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® (2026), 0 descendants of its own

## Indications for use
ViSiGi 3D is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, and to serve as a sizing guide.

Source page: https://510kreport.com/device/K234145
Methodology: https://510kreport.com/methodology