FDA 510(k) Application Details - K250389

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K250389
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. No. 51, Shuishan Road, Zhonglou Economic Development Zone Changzhou 2133023 CN Other 510(k) Applications for this Company
Contact	Hong Zhou Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2025
Decision Date	04/10/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review