FDA 510(k)

XNY Disposable Gastric Calibration Tube

K-번호: K250389 · 2025-04-10

신청자Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

결정일2025-04-10

제품 코드KNT

자문 위원회GU

결정Substantially Equivalent

기기 요약

XNY Disposable Gastric Calibration Tube is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250389. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K250389.

When did XNY Disposable Gastric Calibration Tube receive FDA 510(k) clearance?

XNY Disposable Gastric Calibration Tube received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250389.

Who is the listed applicant for XNY Disposable Gastric Calibration Tube?

The FDA 510(k) record lists Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XNY Disposable Gastric Calibration Tube?

The FDA product code for XNY Disposable Gastric Calibration Tube is KNT.

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd를 신청인으로 등재한 기타 기록

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