# K240069: Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

- Pathway: 510(k) (Special)
- Applicant: Endolumik
- Decided: Feb 8, 2024 after 30 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: 4 generations back to K002838 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222880: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie), Endolumik, Inc. (2023) Summary page 5.

## Indications for use
The EndolumikGastric Calibration Tube 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 guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

Source page: https://510kreport.com/device/K240069
Methodology: https://510kreport.com/methodology