FDA 510(k) Application Details - K230127

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K230127
Device Name	Catheter, Biliary, Diagnostic
Applicant	Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone Nanjing 210032 CN Other 510(k) Applications for this Company
Contact	Sally He 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	01/17/2023
Decision Date	09/06/2023
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