# K222880: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

- Pathway: 510(k) (Traditional)
- Applicant: Endolumik, Inc.
- Decided: Mar 3, 2023 after 162 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
- K240069: Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) (2024), 0 descendants of its own

## Indications for use
The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) 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, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

Source page: https://510kreport.com/device/K222880
Methodology: https://510kreport.com/methodology