XNY Disposable Gastric Calibration Tube

FDA 510(k) K250389 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Substantially Equivalent

510(k) numberK250389

Submission

Device name
XNY Disposable Gastric Calibration Tube
Applicant
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Changzhou, CN
Received
February 11, 2025
Decision date
April 10, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KNT – Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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Questions and answers

When was XNY Disposable Gastric Calibration Tube cleared by the FDA?

XNY Disposable Gastric Calibration Tube (K250389) received a 510(k) decision of Substantially Equivalent on April 10, 2025, 58 days after the submission was received.

What is the product code of K250389?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.