K250389
- 510(k) number
- K250389
- Device name
- XNY Disposable Gastric Calibration Tube
- Applicant
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd CN
- Product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Decision date
- 2025-04-10
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250389.pdf
Official FDA record: K250389
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.