FDA 510(k) Application Details - K243388

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K243388
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Rd 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	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2024
Decision Date	06/27/2025
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