# K250389: XNY Disposable Gastric Calibration Tube

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Decided: Apr 10, 2025 after 58 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221898: Gastrointestinal Boundary Identifier (GIBI HD), Reshape Lifesciences (2022) Summary page 5.

## Indications for use
XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.

Source page: https://510kreport.com/device/K250389
Methodology: https://510kreport.com/methodology