FDA 510(k) Application Details - K221071

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K221071
Device Name	Catheter, Biliary, Diagnostic
Applicant	Taewoong Medical Co., Ltd 14 Gojeong-ro, Wolgot-myeon Gimpo-si 10022 KR Other 510(k) Applications for this Company
Contact	Jangsoo Lee Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2022
Decision Date	06/09/2022
Decision	SESU - SE - WITH LIMITATIONS
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