FDA 510(k) Application Details - K182520

Device Classification Name	Endoscopic Access Overtube, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K182520
Device Name	Endoscopic Access Overtube, Gastroenterology-Urology
Applicant	Sumitomo Bakelite Co., Ltd 5-8, Higashi-Shinagawa 2-chome Shinagawa-ku 1400002 JP Other 510(k) Applications for this Company
Contact	Shiro Agehama Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2018
Decision Date	05/15/2019
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