XNY Disposable Gastric Calibration Tube
K-Number: K250389 · 2025-04-10
Decision Date2025-04-10
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
XNY Disposable Gastric Calibration Tube is a medical device manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2025-04-10 under approval number K250389. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the XNY Disposable Gastric Calibration Tube?
XNY Disposable Gastric Calibration Tube is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K250389.
When was XNY Disposable Gastric Calibration Tube approved by the FDA?
XNY Disposable Gastric Calibration Tube received FDA 510(k) clearance on 2025-04-10, under approval number K250389.
What company makes XNY Disposable Gastric Calibration Tube?
XNY Disposable Gastric Calibration Tube is manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd.
What is the FDA product code for XNY Disposable Gastric Calibration Tube?
The FDA product code for XNY Disposable Gastric Calibration Tube is KNT.
Related Clinical Trials
Other Devices by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar
Related Devices (Code: KNT)
K163092TubeClear Control Box and Clearing StemActuated Medical, Inc.
K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health
K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc.
K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd.
K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd.
K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.