FDA 510(k) Application Details - K250663

Device Classification Name	Stent,Metallic,Expandable,Duodenal   More FDA Info for this Device
510(K) Number	K250663
Device Name	Stent,Metallic,Expandable,Duodenal
Applicant	Taewoong Medical Co., Ltd. 14, Gojeong-ro Wolgot-myeon, Gimpo-si Gyeonggi-do 10022 KR Other 510(k) Applications for this Company
Contact	Yongjin "Jeff" Kim Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	MUM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2025
Decision Date	03/31/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review