# K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Laboratories, LLC
- Decided: May 6, 2024 after 138 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 4.

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

## Indications for use
ViSiGi@ LUX 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/K234033
Methodology: https://510kreport.com/methodology