510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250389Substantially Equivalent

XNY Disposable Gastric Calibration Tube

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, Changzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250389 is the FDA 510(k) clearance record for XNY Disposable Gastric Calibration Tube, a class II device, cleared for Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 3 510(k) clearances for Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, from to . As of , FDA records show no recalls naming K250389.

Clearance record

Decision date
Received
(58 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd # 51, Shuishan Rd., Zhonglou Economic Development Zone, Changzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260